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Low Dose CT
Lung Cancer
Screening
Update
2015
Clay H. Napper, M.D.
LET’S START OFF
WITH A TEST
We’re going to look at some
radiographs to see if we
can detect lung cancer.
ENEMY
• Easy
• Even without
the
annotations.
???
THERE IS A 1.2 CM
LUNG CANCER IN
THE RIGHT LOWER
LOBE
O
It is
imperceptibl
e
Facts Regarding Chest
Radiographs
– Chest radiographs are limited in sensitivity
– Lesions are rarely seen if < 1 cm
– Lesions are reliably seen ONLY if > 2.5 cm
– Many lung cancers are not detected by CXR until
they are advanced stage, often with nodal
involvement and distant metastases.
Facts Regarding Chest
Radiographs
– Chest radiographs are limited in sensitivity
– Lesions are rarely seen if < 1 cm
– Lesions are reliably seen ONLY if > 2.5 cm
– Many lung cancers are not detected by CXR until
they are advanced stage, often with nodal
involvement and distant metastases.
Facts Regarding Chest
Radiographs
– Chest radiographs are limited in sensitivity
– Lesions are rarely seen if < 1 cm
– Lesions are reliably seen ONLY if > 2.5 cm
– Many lung cancers are not detected by CXR until
they are advanced stage, often with nodal
involvement and distant metastases.
Facts Regarding Chest
Radiographs
– Chest radiographs are limited in sensitivity
– Lesions are rarely seen if < 1 cm
– Lesions are reliably seen ONLY if > 2.5 cm
– Many lung cancers are not detected by CXR until
they are advanced stage, often with nodal
involvement and distant metastases.
Facts Regarding Chest
Radiographs
–Many lung cancers are not detected by
CXR until they are advanced stage,
often with nodal involvement and distant
metastases.
So if CXR can’t
reliably detect
small lung cancers
at an early,
treatable stage,…
So if CXR can’t
reliably detect
small lung cancer
at an early,
treatable stage,…
Shouldn’t we
come up with a
more reliable
screening tool?
Low
Dose
Computed
Tomography
Low
Dose
Computed
Tomography
LDCT
O
Remember
the 1.2 cm
RLL nodule?
Remember
the 1.2 cm
RLL nodule?
Imperceptible
on CXR…
O
Plain as day
by LDCT
What we know and what we
have known for a long time:
What we know and what we
have known for a long time.
1. Lung Cancer is not rare.
Projected New Lung Cancer
Diagnoses in the United States
for 2015
Lung Cancer Diagnoses: > 220,000
Men: > 115,000
Women: > 105,000
Lung Cancer Deaths: >155,000
Men: > 86,000
Women: >71,000
What we know and have known
for a long time.
2. Lung cancer is common. It is the
second most common cancer
diagnosis for women and men in
the United States.
What we know and have known
for a long time.
2. Lung cancer is common.
It is the second most common
cancer diagnosis for women and
men in the United States.
2015 Estimated U.S. New Cancer Diagnoses
in Men and Women
Prostate 26% 29% Breast
Lung and Bronchus 14% 13% Lung and Bronchus
Colon and Rectum 8% 8% Colon and Rectum
Urinary Bladder 7% 7% Uterine Corpus
Melanoma 5% 6% Thyroid
NHL 5% 4% NHL
Kidney & Renal Pelvis 5% 4% Melanoma
Oral Cavity &Pharynx 4% 3% Pancreas
Leukemia 4% 3% Leukemia
Liver and Biliary 3% 3% Kidney & Renal Plvis
All other sites 23% 23% All other sites
MEN WOMEN
What we know and what we
have known for a long time:
• Lung cancer is the second most common
cancer in both women and men
3. LUNG CANCER IS DEADLY
• The leading cause of lung cancer in both
men and women is first hand smoke.
Projected Lung Cancer Deaths
in the United States for 2015
Lung Cancer Deaths: >157,000
Men: > 86,000
Women: >71,000
Projected Lung Cancer Deaths
in the United States for 2015
Lung cancer is currently the leading
cause of cancer deaths for both women
and men in the United States
2015 Estimated U.S. Cancer Death in Men and Women
Lung & bronchus 28% 26% Lung & bronchus
Prostate 9% 15% Breast
Colon and Rectum 8% 9% Colon & rectum
Pancreas 7% 7% Pancreas
Leukemia 5% 5% Ovary
Liver and Biliary 5% 4% Leukemia
Esophagus 4% 4% NHL
NHL 4% 4% Uterine corpus
Urinary Bladder 4% 3% Liver and Biliary
Kidney 3% 2% Brain/CNS
All other sites 23% 23% All other sites
MEN WOMEN
What we know and have known
for a long time
1. Lung cancer is not uncommon
2. Lung cancer is common
3. Lung cancer is deadly
4. Smoking cigarettes causes
lung cancer.
What we know and have known
for a long time
1. Lung cancer is not uncommon
2. Lung cancer is common
3. Lung cancer is deadly
4. The number one cause of
lung cancer is first hand
smoke.
Smoking Cigarettes Kills
Tobacco and
Lung Cancer
Risk
– Lung Cancer is the leading cause of cancer death in
both men and women.
– 85% of lung cancer in the United states can
be directly related to smoking.
– There is a large population of smokers in the United
States.
– There are approximately 60 million current smokers
and 30 million former smokers in the United States
Tobacco and
Lung Cancer
Risk
– Lung Cancer is the leading cause of cancer death in
both men and women.
– 85% of lung cancer in the United states can be directly
related to smoking.
– There is a large population of smokers in the United
States.
– There are approximately 60 million current smokers
and 30 million former smokers in the United States
Tobacco and
Lung Cancer
Risk
There are approximately
60 million current smokers
and
30 million former smokers
in the United States
Smoking Cigarettes Kills
Smoking Cigarettes Kills
In the U.S,
approximately
443,000 Deaths
will be
attributed to
cigarette
smoking this
year
129,000 Lung Cancer
126,000 Ischemic Heart
Disease
93,000 COPD
35,300 Other Cancers
15,900 Stroke
44,000 Other Diagnoses
Those are the issues
What should we do?
What should we do?
Campaign against smoking by providing
information and tools to help our patients
quit smoking and encourage them to stay
quit.
Establish an effective screening tool to
detect lung cancer early, at a stage when
treatment can be successful.
What should we do?
Campaign against smoking by providing
information and tools to help our patients
quit smoking and encourage them to stay
quit.
Establish effective screening tools to
detect lung cancer early, at a stage when
treatment can be successful.
History of Lung Cancer
Screening
Lung Cancer Screening
In the 1970’s and 1980’s randomized and
nonrandomized trials and retrospective studies
were performed using CXRs to try to screen for
early, treatable lung cancer.
None of these trial showed a survival benefit for
screening CXRs. Lung cancer death rates for
patients screened with an annual PA chest
radiograph were essentially equal to the lung
cancer death rates for patients who received no
screening at all.
Lung Cancer Screening
In the 1970’s and 1980’s randomized and
nonrandomized trials and retrospective studies
were performed using CXRs to try to screen for
early, treatable lung cancer.
None of these trial showed a survival benefit for
screening CXRs. Lung cancer death rates for
patients screened with an annual PA chest
radiograph were essentially equal to the lung
cancer death rates for patients who received no
screening at all.
Lung Cancer Screening
In the 1970’s and 1980’s randomized and
nonrandomized trials and retrospective studies
were performed using CXRs to try to screen for
early, treatable lung cancer.
None of these trial showed a survival benefit for
screening CXRs. Lung cancer death rates for
patients screened with an annual PA chest
radiograph were essentially equal to the lung
cancer death rates for patients who received
no screening at all.
Lung Cancer Screening
In the 1980’s with the development of CT imaging,
it became apparent that some very small lung
nodules could be reliably detected, and there was
hope that CT screening for lung cancer might be
an effective tool some day.
Lung Cancer Screening
In the 1980’s with the development of CT imaging,
it became apparent that some very small lung
nodules could be reliably detected and that CT
screening for lung cancer might be an effective
tool some day.
But CT imaging was not yet widely available, and it
was neither time nor cost efficient.
Lung Cancer Screening
In the 1990’s, with the advent of more available
and faster CT scanners, some nonrandomized
trials and retrospective analyses showed that CT
could indeed detect early, treatable lung cancer.
Lung Cancer Screening
In the 1990’s some nonrandomized trials and
retrospective analyses showed that CT could
indeed detect early, treatable lung cancer.
However, there had been no large, randomized
clinical trials to absolutely prove the survival
benefits of lung cancer screening with CT
Lung Cancer Screening
• Then, in the early 2000’s, several large
trials were crafted to prove the efficacy of
CT for lung cancer screening.
I-ELCAP Early Lung Cancer Action Program
MPHS was a participant
NLST National Lung Screening Trial
Lung Cancer Screening
• Then, in the early 2000’s, several large
trials were crafted to prove the efficacy of
CT for lung cancer screening.
I-ELCAP Early Lung Cancer Action Program
MPHS was a participant
NLST National Lung Screening Trial
Lung Cancer Screening
• Then, in the early 2000’s, several large
trials were crafted to prove the efficacy of
CT for lung cancer screening.
I-ELCAP Early Lung Cancer Action Program
MPHS was a participant
NLST National Lung Screening Trial
I-ELCAP
• Non-randomized trial involving 31,000
patient screened with LDCT that showed
significant 10 year survival benefit due to
detection of small lung cancers at an early
stage.
• Criticized for being non-randomized
I-ELCAP
• Non-randomized trial involving 31,000
patient screened with LDCT that showed a
significant 10 year survival benefit due to
detection of small lung cancers at an early
stage.
• Criticized for being non-randomized
NLST
Randomized trial beginning in 2002 studying
53,454 subjects, randomized to be screened
with either annual LDCT or annual CXR for
3 years.
The patients were then followed clinically for
an additional 3.5 years.
The goal was to prove a survival benefit of
screening with LDCT
NLST
Randomized trial beginning in 2002 studying
53,454 subjects, randomized to be screened
with either annual LDCT or annual CXR for
3 years.
The patients were then followed clinically for
an additional 3.5 years.
The goal was to prove a survival benefit of
screening with LDCT
NLST
Randomized trial beginning in 2002 studying
53,454 subjects, randomized to be screened
with either annual LDCT or annual CXR for
3 years.
The patients were then followed clinically for
an additional 3.5 years.
The goal was to prove a survival benefit of
screening with LDCT
NLST
In November of 2010, the NLST closed
early because the study had reached its
endpoint.
There was evidence of a 20% lung cancer
mortality reduction using LDCT vs CXR.
There was also evidence of a 6.7 % all
cause mortality reduction.
NLST
In November of 2010, the NSLT was closed
early because the study had reached its
endpoint.
There was evidence of a 20% lung cancer
mortality reduction using LDCT vs. CXR
There was evidence of a 6.7 % all cause
mortality reduction (including additional findings such as
coronary artery disease, thyroid cancer, renal cancers).
NLST
It was shown that screening for lung cancer
with LDCT could prevent one lung cancer
death for every 320 patients screened.
NSLT
It was shown that screening for lung cancer
with LDCT could prevent one lung cancer
death for every 320 patients screened.
In comparison, it takes 1339 individuals
screened with mammography to prevent one
breast cancer death.
For flexible colonoscopy it takes 817
screened patients to prevent one colorectal
cancer death.
NSLT
It was shown that screening for lung cancer
with LDCT could prevent one lung cancer
death for every 320 patients screened.
In comparison, it takes 1339 individuals
screened with mammography to prevent one
breast cancer death.
It takes 817 patients screened with flexible
colonoscopy to prevent one colorectal
cancer death.
NLST
The original results showing the survival
benefit of LDCT screening for lung cancer
were published in the NEJM in August 2011
In November 2011, an article outlining the
cost effectiveness of LDCT was published in
the NEJM siting a cost of $81,000 per QALY
gained.
NLST
The original results showing the survival
benefit of LDCT screening for lung cancer
were published in the NEJM in August 2011
In November 2011, an article outlining the
cost effectiveness of LDCT was published in
the NEJM, siting a cost of $81,000 per
QALY gained. (similar to or less than many other currently used
screening tools)
NLST
In November 2011, an article outlining the
cost effectiveness of LDCT was published in
the NEJM siting a cost of $81,000 per QALY
gained.
In the second article, it stated that the final
costs of a LDCT lung cancer screening
program could be significantly decreased
with only modest changes to the
assumptions made in the original study .
USPSTF
December 2013 U.S. Preventative Services
Task Force issued a recommendation of
screening for lung cancer with LDCT with
criteria only slightly modified from NLST:
55-80 years of age
30-pack-year (or greater) smoking history
Current smoker or quit smoking within the
past 15 years.
Asymptomatic (no signs/sxs of lung cancer)
USPSTF
December 2013 U.S. Preventative Services Task Force
issued a recommendation of screening for lung cancer
with LDCT with criteria only slightly modified from NSLT:
Adults 55-80 years of age
30-pack-year (or greater) smoking history
Current smoker or quit smoking within the
past 15 years.
Asymptomatic (no signs/sxs of lung cancer)
USPSTF
December 2013 U.S. Preventative Services Task Force
issued a recommendation of screening for lung cancer
with LDCT with criteria only slightly modified from NSLT:
Adults 55-80 years of age
30-pack-year (or greater) smoking history
Current smoker or quit smoking within the
past 15 years.
Asymptomatic (no signs/sxs of lung cancer)
USPSTF
December 2013 U.S. Preventative Services Task Force
issued a recommendation of screening for lung cancer
with LDCT with criteria only slightly modified from NSLT:
Adults 55-80 years of age
30-pack-year (or greater) smoking history
Current smoker or quit smoking within
the past 15 years.
Asymptomatic (no signs/sxs of lung cancer)
USPSTF
December 2013 U.S. Preventative Services Task Force
issued a recommendation of screening for lung cancer
with LDCT with criteria only slightly modified from NSLT:
Adults 55-80 years of age
30-pack-year (or greater) smoking history
Current smoker or quit smoking within the
past 15 years.
Asymptomatic (no signs/sxs of lung cancer)
USPSTF
The recommendation was issued with a
Grade B favorable rating:
USPSTF
The recommendation was issued with a
Grade B favorable rating:
“There is either a high certainty that the net
benefit of screening is positive
Or
There is a moderate certainty that the net
benefit of screening is substantial.”
USPSTF
The recommendation was issued with a
Grade B favorable rating.
Under the Affordable Care Act (ACA)
private insurers must provide coverage for
LDCT lung screening to qualified patients,
and the screening must be provided
without a co-payment
USPSTF did not make a
statement regarding CMS
CMS
• In March 2015 (15 months later), Centers
for Medicare and Medicaid Services
approved similar coverage (with slight
modifications) for qualifying Medicare and
Medicaid patients.
CMS
• In March 2015 (15 months later), Centers
for Medicare and Medicaid Services
approved similar coverage (with slight
modifications) for qualifying Medicare and
Medicaid patients.
• According to some, the most important
news in Radiology this year.
Let’s Review
LDCT – Who do we screen?
LDCT – Who do we screen?
• First, we try to adhere to USPSTF
guidelines:
LDCT – Who do we screen?
• First, we try to adhere to USPSTF
guidelines:
• Adults age 55-80
LDCT – Who do we screen?
• First, we try to adhere to USPSTF
guidelines:
• Adults age 55-80
• 30-pack-year (or greater) smoking history
LDCT – Who do we screen?
• First, we try to adhere to USPSTF
guidelines:
• Adults age 55-80
• 30-pack-year (or greater) smoking history
• Current smoker or having quit smoking
within the last 15 years.
LDCT – Who do we screen?
• First, we try to adhere to USPSTF
guidelines:
• Adults age 55-80
• 30-pack-year (or greater) smoking history
• Current smoker or having quit smoking
within the last 15 years.
• Asymptomatic – meaning without signs or
symptoms suggestive of lung cancer
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
We also make allowances for patients nearly
meeting criteria who also possess another
known risk factor as laid out in the NCCN
guidelines, including:
• Personal history of cancer
• Family history of lung cancer
• History of asbestos exposure
• History of radon exposure
• Dx of COPD or Pulmonary Fibrosis
LDCT – Who do we screen?
Age 55-80
30-pack-year (or greater) smoking history
Current smoker or quit smoking within the last 15 years.
Without current signs or symptoms suggestive of lung cancer
Of the 60 million current smokers and
30 million former smokers in the U.S.,
somewhere between 7 million and 10
million individuals qualify for screening
with LDCT
LDCT – How is the study
performed?
• Simple for the patient
• No oral or intravenous contrast.
• Time in the Radiology Department is
usually less than an hour spent mostly
checking in, changing into a gown and
being escorted to and positioned on the
CT scanner.
• Actual scan time is 3-7 seconds, an easy
breath hold for almost all patients.
LDCT – How is the study
performed?
• Simple for the patient
• No oral or intravenous contrast.
• Time in the Radiology Department is
usually less than an hour spent mostly
checking in, changing into a gown and
being escorted to and positioned on the
CT scanner.
• Actual scan time is 3-7 seconds, an easy
breath hold for almost all patients.
LDCT – How is the study
performed?
• Simple for the patient
• No oral or intravenous contrast.
• Time in the Radiology Department is
usually less than an hour spent mostly
checking in, changing into a gown and
being escorted to and positioned on the
CT scanner.
• Actual scan time is 3-7 seconds, an easy
breath hold for almost all patients.
LDCT – How is the study
performed?
• Simple for the patient
• No oral or intravenous contrast.
• Time in the Radiology Department is
usually less than an hour spent mostly
checking in, changing into a gown and
being escorted to and positioned on the
CT scanner.
• Actual scan time is 3-7 seconds, an easy
breath hold for almost all patients.
LDCT – How is the study
performed?
The actual scan time is 3-7 seconds
(an easy breath hold for almost all patients)
LDCT – How is the study
performed?
• The examination is performed with a low
dose protocol using the lowest radiation
dose possible to obtain a diagnostic scan.
• Radiation dose from a Low Dose CT falls
in the range of 0.61 – 1.5 mSv
LDCT – How is the study
performed?
• Radiation dose from a LDCT falls in the
range of 0.61 – 1.5 mSv
LDCT – How is the study
performed?
• Radiation dose from a LDCT falls in the
range of 0.61 – 1.5 mSv
What does that mean?
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
– For reference, the background average
annual radiation dose in the U.S. is
approximately 3.1 mSv
– Background radiation dose is affected by
terrestrial and celestial sources of background
radiation
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
– For reference, the background average
annual radiation dose in the U.S. is
approximately 3.1 mSv
– Background radiation dose is affected by
terrestrial and celestial sources of background
radiation
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
• The atmosphere offers some protection
from celestial radiation; so living at lower
altitude has an intrinsically protective
effect and reduces our dose of
background radiation.
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
• Living at lower altitude results in a lower
annual background radiation dose.
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
• The difference in annual background
radiation dose between living in San
Francisco (at sea level) and living in
Denver (mile high) is approximately
1.5 mSv
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
• The difference in annual background
radiation dose between living in San
Francisco (at sea level) and living in
Denver (mile high) is approximately
1.5 mSv
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
•The dose is very low.
Radiation dose from the LDCT falls in
the range of 0.61 – 1.5 mSv
• What does that mean?
•The dose is very low.
•The dose is less than
background differences between
living in Denver and living in San
Francisco.
LDCT – How is the study
interpreted and reported?
• We use LungRADS structured reporting
and guidelines for recommendations
regarding followup and treatment.
LDCT – How is the study
interpreted and reported?
• We use LungRADS structured reporting
and guidelines for recommendations
regarding followup and treatment.
LungRADS
• LungRADS was devised along a
framework similar to BIRADS, the Breast
Imaging reporting system that has been in
use for over 20 years.
LungRADS
• To determine the significance of detected
lung nodules and to determine the
appropriate surveillance or action needed,
LungRADS attends to :
• (1) nodule size
• (2) nodule consistency
• (3) nodule stability
LungRADS
• To determine the significance of detected
lung nodules and to determine the
appropriate surveillance or action needed,
LungRADS attends to :
• (1) nodule size
• (2) nodule consistency
• (3) nodule stability
LungRADS
• To determine the significance of detected
lung nodules and to determine the
appropriate surveillance or action needed,
LungRADS attends to :
• (1) nodule size
• (2) nodule consistency
• (3) nodule stability
LungRADS
• To determine the significance of detected
lung nodules and to determine the
appropriate surveillance or action needed,
LungRADS attends to :
• (1) nodule size
• (2) nodule consistency
• (3) nodule stability
LungRADS
• (1) nodule size
– Larger nodules are more concerning than
smaller nodules
• Smaller nodules are more likely to be
postinflammatory or benign
LungRADS
• (2) nodule consistency
LungRADS
• (2) nodule consistency
– Solid
– Part solid
– Non-solid (ground glass)
• The more solid a nodule or the larger the solid
component of a nodule, the more worrisome the
finding
LungRADS
• (3) nodule stability
– Stability is a marker of benignity
• Growing or changing nodules or nodules that have
newly developed since previous imaging are more
concerning
LungRADS
• (3) nodule
stability
20132015
LungRADS
• (3) nodule
stability
20132015
Adenocarcinoma
in situ
LungRADS
• (3) nodule
stability
20132015
Adenocarcinoma
in situ
Minimally invasive
adenocarcinoma
LungRADS
• LungRADS categorizes the findings of a
LDCT lung screening examination with a
numeric value (0 to 4, increasing in level of
concern) with a corresponding established
recommendation for followup imaging or
other action.
reported?BASIC CHART
showing
LungRADS
categories and
corresponding
recommendations
Complete Chart including nodule size, consistency and stability
LungRADS Categories
LungRADS
• CATEGORY 0: “INCOMPLETE”
LungRADS
• CATEGORY 0: “INCOMPLETE”
– Images degraded by motion
– The region of interest is not entirely included
LungRADS
• CATEGORY 0: “INCOMPLETE”
– Images degraded by motion
– The region of interest is not entirely included
PATIENT NEEDS TO BE RECALLED FOR
COMPLETION OF IMAGING
LungRADS
• CATEGORY 1: “NEGATIVE”
LungRADS
• CATEGORY 1: “NEGATIVE”
– EITHER NO LUNG NODULES OR ONLY
DEFINITELY BENIGN NODULES
(granulomas, hamartomas, etc.)
LungRADS
• CATEGORY 1: “NEGATIVE”
– EITHER NO LUNG NODULES OR ONLY
DEFINITELY BENIGN NODULES
(granulomas, hamartomas, etc.)
FOLLOWUP LDCT IN ONE YEAR
LungRADS
• CATEGORY 2: “BENIGN”
LungRADS
• CATEGORY 2: “BENIGN”
– VERY SMALL NODULES (<6mm) OR
NODULES THAT ARE KNOWN TO BE
STABLE OR DECREASING IN SIZE
LungRADS
• CATEGORY 2: “BENIGN”
– SMALL LUNG NODULES AND NODULES
WITH PROVEN STABILITY
FOLLOWUP LDCT IN ONE YEAR
LungRADS
• CATEGORY 3: “PROBABLY BENIGN”
LungRADS
• CATEGORY 3: “PROBABLY BENIGN”
– SLIGHTLY LARGER BUT STILL SMALL
NODULES WITHOUT PROVEN STABILITY
LungRADS
• CATEGORY 3: “PROBABLY BENIGN”
– SLIGHTLY LARGER BUT STILL SMALL
NODULES WITHOUT PROVEN STABILITY
SHORTER TERM FOLLOWUP LDCT IN
6 MONTHS
To establish stability or regression and exclude lesion growth
LungRADS
• CATEGORY 4: “SUSPICIOUS”
LungRADS
• CATEGORY 4: “SUSPICIOUS”
– LARGER NODULES OR SUSPICIOUS
APPEARING NODULES WITHOUT PROVEN
STABILITY
LungRADS
• CATEGORY 4: “SUSPICIOUS”
– LARGER NODULES OR SUSPICIOUS
APPEARING NODULES WITHOUT PROVEN
STABILITY
3-MONTH CT FOLLOWUP, ADDITIONAL
CHARACTERIZATION WITH PET-CT OR
TISSUE SAMPLING
(BRONCHOSCOPY, PERCUTANEOUS NEEDLE BIOPSY,
EXCISIONAL BIOPSY, VATS, MEDIASTINOSCOPY)
LungRADS
• CATEGORY 4: “SUSPICIOUS”
The vast majority of these findings are
followed with imaging alone.
LungRADS
• CATEGORY 4: “SUSPICIOUS”
The vast majority of these findings are
followed with imaging alone.
Only about 1% of initial CT lung screens result
in a need for tissue sampling.
What Constitutes a NEGATIVE
Screen?
What Constitutes a NEGATIVE
Screen?
• Any LDCT for which annual LDCT
followup is recommended
What Constitutes a NEGATIVE
Screen?
• Any LDCT for which annual LDCT
followup is recommended
• LungRADS categories 1 and 2
• “Negative” or “Benign”
What Constitutes a NEGATIVE
Screen?
• Any LDCT for which annual LDCT
followup is recommended
• LungRADS categories 1 and 2
• “Negative” or “Benign”
• >90% of all initial screens
What Constitutes a Positive Screen?
What Constitutes a Positive Screen?
• Any LDCT finding for which follow up other
than annual screening is recommended.
What Constitutes a Positive Screen?
–LungRADS 3 “Probably Benign”
• (6 mos f/u LDCT)
• ~5% of initial screens
–LungRADS 4 “Suspicious”
• (3 mos f/u, PET-CT, and/or tissue
sampling)
• ~4% total, most being followed with
LDCT in 3 mos or with CT or PET-CT
What Constitutes a Positive Screen?
–LungRADS 3 “Probably Benign”
• (6 mos f/u LDCT)
• ~5%
–LungRADS 4 “Suspicious”
• (3 mos f/u CT, PET-CT, and/or tissue
sampling)
• ~4% of initial screens, most being followed
with imaging
What Constitutes a Positive Screen?
–LungRADS 4 “Suspicious”
• (3 mos f/u, PET-CT, and/or tissue
sampling)
• ~4% total, most being followed with
LDCT in 3 mos or with CT or PET-CT
• Only approximately 1% of initial
screenings result in a recommendation
for tissue sampling. The rest are further
evaluated with imaging alone.
Practice Parameters for the
performance and interpretation of
LDCT for Lung Cancer Screening
Established by ACR and STR
Designated Lung Screening Center under CT
accreditation program for equipment, imaging
protocols, and interpreting radiologists.
LungRADS structured reporting and management
tool
Participate in a Lung Cancer Screening Registry
Follow patient selection guidelines
Practice Parameters were established
by agreement between many interested
organizations
Practice Parameters for the
performance and interpretation of
LDCT for Lung Cancer Screening
Screening should be performed at a designated
Lung Screening Center under a CT accreditation
program that specifies CT equipment, imaging
protocols, and experience and skills of the
interpreting radiologists.
LungRADS structured reporting and management
tool should be employed
Participate in a Lung Cancer Screening Registry
Follow patient selection guidelines
Practice Parameters for the
performance and interpretation of
LDCT for Lung Cancer Screening
Screening should be performed at a designated
Lung Screening Center under a CT accreditation
program for equipment, imaging protocols, and
interpreting radiologists.
LungRADS structured reporting and management
tool should be employed for reporting and decision
making.
Participate in a Lung Cancer Screening Registry
Patient selection guidelines should be followed
Practice Parameters for the
performance and interpretation of
LDCT for Lung Cancer Screening
Screening should be performed at a designated
Lung Screening Center under a CT accreditation
program for equipment, imaging protocols, and
interpreting radiologists.
LungRADS structured reporting and management
tool
The screening center should participate in a Lung
Cancer Screening Registry
Patient Selection guidelines should be followed
Practice Parameters for the
performance and interpretation of
LDCT for Lung Cancer Screening
Screening should be performed at a designated
Lung Screening Center under a CT accreditation
program for equipment, imaging protocols, and
interpreting radiologists.
LungRADS structured reporting and management
tool
The screening center should participate in a Lung
Cancer Screening Registry
Patient selection guidelines should be followed
LDCT: Referring Provider
What are the roles of the referring provider?
LDCT: Referring Provider
• Complete an order for LDCT
• Affirm the patient’s eligibility (usually a
checkbox form)
• Provide shared decision making with the
patient prior to the first screening LDCT
LDCT: Referring Provider
• Complete an order for LDCT
• Affirm the patient’s eligibility (usually a
checkbox form)
• Provide shared decision making with the
patient prior to the first screening LDCT
LDCT: Referring Provider
• Complete an order for LDCT
• Affirm the patient’s eligibility (usually a
checkbox form)
• Provide shared decision making with the
patient prior to the first screening LDCT
LDCT: Shared Decision Making
• What is shared decision making?
LDCT: Shared Decision Making
• Information sharing between the patient
and physician regarding the potential
benefits and harms of undergoing LDCT.
Benefits:
• Detecting early lung cancer in it’s treatable
stages.
• Detecting other unknown treatable findings
• Encouragement of smoking cessation
LDCT: Shared Decision Making
• Information sharing between the patient
and physician regarding the potential
benefits and harms of undergoing LDCT.
Benefits:
• Detecting early lung cancer in it’s treatable
stages.
• Detecting other treatable findings
• Encouragement of smoking cessation
LDCT: Shared Decision Making
• Information sharing between the patient
and physician regarding the potential
benefits and harms of undergoing LDCT.
Benefits:
• Detecting early lung cancer in it’s treatable
stages.
• Detecting other treatable findings
• Encouragement of smoking cessation
LDCT: Shared Decision Making
• Information sharing between the patient
and physician regarding the potential
benefits and harms of undergoing LDCT.
Benefits:
• Detecting early lung cancer in it’s treatable
stages.
• Detecting other treatable findings
• Encouragement of smoking cessation
LDCT: Shared Decision Making
Potential Harms:
•Radiation exposure (as little as possible --
similar to the difference between living in SF
versus Denver for a year
•False positive results – findings that require
additional follow up, imaging, or tissue
sampling that do not eventually prove to be
lung cancer.
LDCT: Shared Decision Making
Potential Harms:
•Radiation exposure (as little as possible --
similar to the difference between living in SF
versus Denver for a year
•False positive results – findings that require
additional follow up, imaging, or tissue
sampling that do not eventually prove to be
lung cancer.
LDCT: Shared Decision Making
Potential Harms:
•Overdiagnosis – the phenomenon of
detecting a lung cancer that is so indolent
that it would not go on to result in lung
cancer death if it remained undetected and
untreated.
LDCT: Shared Decision Making
Several excellent tools provide guidance
regarding shared decision making and
provide patients with useful information
regarding potential benefits and harms of
lung cancer screening with LDCT
LDCT: Shared Decision Making
Should I Screen?
http://www.shouldiscreen.com/
Web based decision making aid with a risk
calculator that patients can use to determine their
risk of developing lung cancer based on factor
including age, smoking history, personal cancer
history, family lung cancer history, history of COPD
or pulmonary fibrosis
LDCT: Shared Decision Making
Should I Screen?
http://www.shouldiscreen.com/
Web based decision making aid that describes
lung cancer, lung cancer screening, the dangers of
smoking and provides a risk calculator that
patients can use to determine their risk of
developing lung cancer based on their age and
personal risk factor profile.
Should I Screen?
NCCN Lung Cancer
Screening Booklet
LDCT: Shared Decision Making
http://www.nccn.org/patients/guidelines/lung_s
creening/
Web based booklet provided by the National
Comprehensive Cancer Network that can be
navigated online or printed.
Provides patients with educational materials to help
inform them of the potential benefits and harms of
lung cancer screening with LDCT
LDCT: Shared Decision Making
http://www.nccn.org/patients/guidelines/lung_s
creening/
Web based booklet provided by the National
Comprehensive Cancer Network that can be
navigated online or printed.
Provides patients with educational materials to help
inform them of the potential benefits and harms of
lung cancer screening with LDCT
NCCN
What’s do we do next?
• Talk to your patients about smoking
cessation and help them decide if LDCT
screening for lung cancer is right for them
• Refer appropriate patients for LDCT at a
reputable, accredited screening facility.
• Stay informed.
What’s do we do next?
• Talk to your patients about smoking
cessation and help them decide if LDCT
screening for lung cancer is right for them
• Refer appropriate patients for LDCT at a
reputable, accredited screening facility.
• Stay informed.
What’s do we do next?
• Talk to your patients about smoking
cessation and help them decide if LDCT
screening for lung cancer is right for them
• Refer appropriate patients for LDCT at a
reputable, accredited screening facility.
• Stay informed.
What’s do we do next?
• Talk to your patients about smoking
cessation and help them decide if LDCT
screening for lung cancer is right for them
• Refer appropriate patients for LDCT at a
reputable, accredited screening facility.
• Stay informed. The landscape is changing
daily, and there new information and new
ideas are emerging all the time.
Low Dose CT
Lung Cancer
Screening
Update
2015
Clay H. Napper, M.D.
Thank
you for
your
attention
Stay Informed - Changing
Landscape
• Journal of the National Cancer Institute
– October 19, 2015 (hot off the press)
“CT lung cancer screening may benefit
even those with fewer than 30 pack-
years of smoking history.” After reviewing the
“records of more than 30,000 smokers and former smokers who participated in
the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) and
had smoking histories ranging from 20 to 29 pack-years,” researchers found that
“their risk of developing cancer was very similar to that of patients eligible for
screening in the National Lung Screening Trial (NLST), which focused on
individuals with smoking histories of 30 pack-years or more.”
Radiographic Differential Diagnosis
• Post-inflammatory granuloma (80%)
• Benign neoplasm (e.g. hamartoma)
• Pulmonary AVM
• Solitary lung metastasis
• Primary lung cancer
• Other miscellaneous nodules (nodular sarcoid,
rheumatoid nodule, pulmonary-renal syndrome granuloma,
bronchogenic cyst, hematoma, abscess, others…)
• Solitary pulmonary nodule
• Rates of Growth
– Volume doubling time for most bronchial /lung
carcinomas is 1-18 months.
– A 26% increase in diameter is equivalent to a
doubling in volume
• 5 mm --> 6.3 mm --> 7.7 mm
• 10 mm --> 12.6 mm --> 15
• For small lesions, growth may not be perceptible until the
tumor has doubled or even quadrupled in volume
• Solitary pulmonary nodule
• Rates of Growth
– Volume doubling time for most bronchial/lung carcinomas is 1-18
months.
– Volume doubling is equivalent to only a 26% increase
in diameter
For small lesions, growth may not be perceptible until
the tumor has doubled or even quadrupled in volume
• 5 mm --> 6.3 mm --> 7.7 mm
• 10 mm --> 12.6 mm --> 15
Applications
• Solitary pulmonary nodule: Percutaneous BX
• Risks of Percutaneous Biopsy
– Pneumothorax 20-25%
– Chest tube required 5-10%
– Hemoptysis 5%
– Malignant seeding 0.01%
– Air embolism 0.1%
– Death 0.2%

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Low dose ct lung cancer screening update

  • 1.
  • 2. Low Dose CT Lung Cancer Screening Update 2015 Clay H. Napper, M.D.
  • 4. We’re going to look at some radiographs to see if we can detect lung cancer.
  • 5.
  • 6. ENEMY • Easy • Even without the annotations.
  • 7. ???
  • 8. THERE IS A 1.2 CM LUNG CANCER IN THE RIGHT LOWER LOBE
  • 9. O
  • 11. Facts Regarding Chest Radiographs – Chest radiographs are limited in sensitivity – Lesions are rarely seen if < 1 cm – Lesions are reliably seen ONLY if > 2.5 cm – Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.
  • 12. Facts Regarding Chest Radiographs – Chest radiographs are limited in sensitivity – Lesions are rarely seen if < 1 cm – Lesions are reliably seen ONLY if > 2.5 cm – Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.
  • 13. Facts Regarding Chest Radiographs – Chest radiographs are limited in sensitivity – Lesions are rarely seen if < 1 cm – Lesions are reliably seen ONLY if > 2.5 cm – Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.
  • 14. Facts Regarding Chest Radiographs – Chest radiographs are limited in sensitivity – Lesions are rarely seen if < 1 cm – Lesions are reliably seen ONLY if > 2.5 cm – Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.
  • 15. Facts Regarding Chest Radiographs –Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.
  • 16. So if CXR can’t reliably detect small lung cancers at an early, treatable stage,…
  • 17. So if CXR can’t reliably detect small lung cancer at an early, treatable stage,… Shouldn’t we come up with a more reliable screening tool?
  • 21. Remember the 1.2 cm RLL nodule? Imperceptible on CXR…
  • 23. What we know and what we have known for a long time:
  • 24. What we know and what we have known for a long time. 1. Lung Cancer is not rare.
  • 25. Projected New Lung Cancer Diagnoses in the United States for 2015 Lung Cancer Diagnoses: > 220,000 Men: > 115,000 Women: > 105,000 Lung Cancer Deaths: >155,000 Men: > 86,000 Women: >71,000
  • 26. What we know and have known for a long time. 2. Lung cancer is common. It is the second most common cancer diagnosis for women and men in the United States.
  • 27. What we know and have known for a long time. 2. Lung cancer is common. It is the second most common cancer diagnosis for women and men in the United States.
  • 28. 2015 Estimated U.S. New Cancer Diagnoses in Men and Women Prostate 26% 29% Breast Lung and Bronchus 14% 13% Lung and Bronchus Colon and Rectum 8% 8% Colon and Rectum Urinary Bladder 7% 7% Uterine Corpus Melanoma 5% 6% Thyroid NHL 5% 4% NHL Kidney & Renal Pelvis 5% 4% Melanoma Oral Cavity &Pharynx 4% 3% Pancreas Leukemia 4% 3% Leukemia Liver and Biliary 3% 3% Kidney & Renal Plvis All other sites 23% 23% All other sites MEN WOMEN
  • 29. What we know and what we have known for a long time: • Lung cancer is the second most common cancer in both women and men 3. LUNG CANCER IS DEADLY • The leading cause of lung cancer in both men and women is first hand smoke.
  • 30. Projected Lung Cancer Deaths in the United States for 2015 Lung Cancer Deaths: >157,000 Men: > 86,000 Women: >71,000
  • 31. Projected Lung Cancer Deaths in the United States for 2015 Lung cancer is currently the leading cause of cancer deaths for both women and men in the United States
  • 32. 2015 Estimated U.S. Cancer Death in Men and Women Lung & bronchus 28% 26% Lung & bronchus Prostate 9% 15% Breast Colon and Rectum 8% 9% Colon & rectum Pancreas 7% 7% Pancreas Leukemia 5% 5% Ovary Liver and Biliary 5% 4% Leukemia Esophagus 4% 4% NHL NHL 4% 4% Uterine corpus Urinary Bladder 4% 3% Liver and Biliary Kidney 3% 2% Brain/CNS All other sites 23% 23% All other sites MEN WOMEN
  • 33. What we know and have known for a long time 1. Lung cancer is not uncommon 2. Lung cancer is common 3. Lung cancer is deadly 4. Smoking cigarettes causes lung cancer.
  • 34. What we know and have known for a long time 1. Lung cancer is not uncommon 2. Lung cancer is common 3. Lung cancer is deadly 4. The number one cause of lung cancer is first hand smoke.
  • 35.
  • 37. Tobacco and Lung Cancer Risk – Lung Cancer is the leading cause of cancer death in both men and women. – 85% of lung cancer in the United states can be directly related to smoking. – There is a large population of smokers in the United States. – There are approximately 60 million current smokers and 30 million former smokers in the United States
  • 38. Tobacco and Lung Cancer Risk – Lung Cancer is the leading cause of cancer death in both men and women. – 85% of lung cancer in the United states can be directly related to smoking. – There is a large population of smokers in the United States. – There are approximately 60 million current smokers and 30 million former smokers in the United States
  • 39. Tobacco and Lung Cancer Risk There are approximately 60 million current smokers and 30 million former smokers in the United States
  • 42. In the U.S, approximately 443,000 Deaths will be attributed to cigarette smoking this year 129,000 Lung Cancer 126,000 Ischemic Heart Disease 93,000 COPD 35,300 Other Cancers 15,900 Stroke 44,000 Other Diagnoses
  • 43. Those are the issues
  • 45. What should we do? Campaign against smoking by providing information and tools to help our patients quit smoking and encourage them to stay quit. Establish an effective screening tool to detect lung cancer early, at a stage when treatment can be successful.
  • 46. What should we do? Campaign against smoking by providing information and tools to help our patients quit smoking and encourage them to stay quit. Establish effective screening tools to detect lung cancer early, at a stage when treatment can be successful.
  • 47. History of Lung Cancer Screening
  • 48. Lung Cancer Screening In the 1970’s and 1980’s randomized and nonrandomized trials and retrospective studies were performed using CXRs to try to screen for early, treatable lung cancer. None of these trial showed a survival benefit for screening CXRs. Lung cancer death rates for patients screened with an annual PA chest radiograph were essentially equal to the lung cancer death rates for patients who received no screening at all.
  • 49. Lung Cancer Screening In the 1970’s and 1980’s randomized and nonrandomized trials and retrospective studies were performed using CXRs to try to screen for early, treatable lung cancer. None of these trial showed a survival benefit for screening CXRs. Lung cancer death rates for patients screened with an annual PA chest radiograph were essentially equal to the lung cancer death rates for patients who received no screening at all.
  • 50. Lung Cancer Screening In the 1970’s and 1980’s randomized and nonrandomized trials and retrospective studies were performed using CXRs to try to screen for early, treatable lung cancer. None of these trial showed a survival benefit for screening CXRs. Lung cancer death rates for patients screened with an annual PA chest radiograph were essentially equal to the lung cancer death rates for patients who received no screening at all.
  • 51. Lung Cancer Screening In the 1980’s with the development of CT imaging, it became apparent that some very small lung nodules could be reliably detected, and there was hope that CT screening for lung cancer might be an effective tool some day.
  • 52. Lung Cancer Screening In the 1980’s with the development of CT imaging, it became apparent that some very small lung nodules could be reliably detected and that CT screening for lung cancer might be an effective tool some day. But CT imaging was not yet widely available, and it was neither time nor cost efficient.
  • 53. Lung Cancer Screening In the 1990’s, with the advent of more available and faster CT scanners, some nonrandomized trials and retrospective analyses showed that CT could indeed detect early, treatable lung cancer.
  • 54. Lung Cancer Screening In the 1990’s some nonrandomized trials and retrospective analyses showed that CT could indeed detect early, treatable lung cancer. However, there had been no large, randomized clinical trials to absolutely prove the survival benefits of lung cancer screening with CT
  • 55. Lung Cancer Screening • Then, in the early 2000’s, several large trials were crafted to prove the efficacy of CT for lung cancer screening. I-ELCAP Early Lung Cancer Action Program MPHS was a participant NLST National Lung Screening Trial
  • 56. Lung Cancer Screening • Then, in the early 2000’s, several large trials were crafted to prove the efficacy of CT for lung cancer screening. I-ELCAP Early Lung Cancer Action Program MPHS was a participant NLST National Lung Screening Trial
  • 57. Lung Cancer Screening • Then, in the early 2000’s, several large trials were crafted to prove the efficacy of CT for lung cancer screening. I-ELCAP Early Lung Cancer Action Program MPHS was a participant NLST National Lung Screening Trial
  • 58. I-ELCAP • Non-randomized trial involving 31,000 patient screened with LDCT that showed significant 10 year survival benefit due to detection of small lung cancers at an early stage. • Criticized for being non-randomized
  • 59. I-ELCAP • Non-randomized trial involving 31,000 patient screened with LDCT that showed a significant 10 year survival benefit due to detection of small lung cancers at an early stage. • Criticized for being non-randomized
  • 60. NLST Randomized trial beginning in 2002 studying 53,454 subjects, randomized to be screened with either annual LDCT or annual CXR for 3 years. The patients were then followed clinically for an additional 3.5 years. The goal was to prove a survival benefit of screening with LDCT
  • 61. NLST Randomized trial beginning in 2002 studying 53,454 subjects, randomized to be screened with either annual LDCT or annual CXR for 3 years. The patients were then followed clinically for an additional 3.5 years. The goal was to prove a survival benefit of screening with LDCT
  • 62. NLST Randomized trial beginning in 2002 studying 53,454 subjects, randomized to be screened with either annual LDCT or annual CXR for 3 years. The patients were then followed clinically for an additional 3.5 years. The goal was to prove a survival benefit of screening with LDCT
  • 63. NLST In November of 2010, the NLST closed early because the study had reached its endpoint. There was evidence of a 20% lung cancer mortality reduction using LDCT vs CXR. There was also evidence of a 6.7 % all cause mortality reduction.
  • 64. NLST In November of 2010, the NSLT was closed early because the study had reached its endpoint. There was evidence of a 20% lung cancer mortality reduction using LDCT vs. CXR There was evidence of a 6.7 % all cause mortality reduction (including additional findings such as coronary artery disease, thyroid cancer, renal cancers).
  • 65. NLST It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened.
  • 66. NSLT It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened. In comparison, it takes 1339 individuals screened with mammography to prevent one breast cancer death. For flexible colonoscopy it takes 817 screened patients to prevent one colorectal cancer death.
  • 67. NSLT It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened. In comparison, it takes 1339 individuals screened with mammography to prevent one breast cancer death. It takes 817 patients screened with flexible colonoscopy to prevent one colorectal cancer death.
  • 68. NLST The original results showing the survival benefit of LDCT screening for lung cancer were published in the NEJM in August 2011 In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM siting a cost of $81,000 per QALY gained.
  • 69. NLST The original results showing the survival benefit of LDCT screening for lung cancer were published in the NEJM in August 2011 In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM, siting a cost of $81,000 per QALY gained. (similar to or less than many other currently used screening tools)
  • 70. NLST In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM siting a cost of $81,000 per QALY gained. In the second article, it stated that the final costs of a LDCT lung cancer screening program could be significantly decreased with only modest changes to the assumptions made in the original study .
  • 71. USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NLST: 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)
  • 72. USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NSLT: Adults 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)
  • 73. USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NSLT: Adults 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)
  • 74. USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NSLT: Adults 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)
  • 75. USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NSLT: Adults 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)
  • 76. USPSTF The recommendation was issued with a Grade B favorable rating:
  • 77. USPSTF The recommendation was issued with a Grade B favorable rating: “There is either a high certainty that the net benefit of screening is positive Or There is a moderate certainty that the net benefit of screening is substantial.”
  • 78. USPSTF The recommendation was issued with a Grade B favorable rating. Under the Affordable Care Act (ACA) private insurers must provide coverage for LDCT lung screening to qualified patients, and the screening must be provided without a co-payment
  • 79. USPSTF did not make a statement regarding CMS
  • 80. CMS • In March 2015 (15 months later), Centers for Medicare and Medicaid Services approved similar coverage (with slight modifications) for qualifying Medicare and Medicaid patients.
  • 81. CMS • In March 2015 (15 months later), Centers for Medicare and Medicaid Services approved similar coverage (with slight modifications) for qualifying Medicare and Medicaid patients. • According to some, the most important news in Radiology this year.
  • 83. LDCT – Who do we screen?
  • 84. LDCT – Who do we screen? • First, we try to adhere to USPSTF guidelines:
  • 85. LDCT – Who do we screen? • First, we try to adhere to USPSTF guidelines: • Adults age 55-80
  • 86. LDCT – Who do we screen? • First, we try to adhere to USPSTF guidelines: • Adults age 55-80 • 30-pack-year (or greater) smoking history
  • 87. LDCT – Who do we screen? • First, we try to adhere to USPSTF guidelines: • Adults age 55-80 • 30-pack-year (or greater) smoking history • Current smoker or having quit smoking within the last 15 years.
  • 88. LDCT – Who do we screen? • First, we try to adhere to USPSTF guidelines: • Adults age 55-80 • 30-pack-year (or greater) smoking history • Current smoker or having quit smoking within the last 15 years. • Asymptomatic – meaning without signs or symptoms suggestive of lung cancer
  • 89. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 90. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 91. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 92. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 93. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 94. LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis
  • 95. LDCT – Who do we screen? Age 55-80 30-pack-year (or greater) smoking history Current smoker or quit smoking within the last 15 years. Without current signs or symptoms suggestive of lung cancer Of the 60 million current smokers and 30 million former smokers in the U.S., somewhere between 7 million and 10 million individuals qualify for screening with LDCT
  • 96. LDCT – How is the study performed? • Simple for the patient • No oral or intravenous contrast. • Time in the Radiology Department is usually less than an hour spent mostly checking in, changing into a gown and being escorted to and positioned on the CT scanner. • Actual scan time is 3-7 seconds, an easy breath hold for almost all patients.
  • 97. LDCT – How is the study performed? • Simple for the patient • No oral or intravenous contrast. • Time in the Radiology Department is usually less than an hour spent mostly checking in, changing into a gown and being escorted to and positioned on the CT scanner. • Actual scan time is 3-7 seconds, an easy breath hold for almost all patients.
  • 98. LDCT – How is the study performed? • Simple for the patient • No oral or intravenous contrast. • Time in the Radiology Department is usually less than an hour spent mostly checking in, changing into a gown and being escorted to and positioned on the CT scanner. • Actual scan time is 3-7 seconds, an easy breath hold for almost all patients.
  • 99. LDCT – How is the study performed? • Simple for the patient • No oral or intravenous contrast. • Time in the Radiology Department is usually less than an hour spent mostly checking in, changing into a gown and being escorted to and positioned on the CT scanner. • Actual scan time is 3-7 seconds, an easy breath hold for almost all patients.
  • 100. LDCT – How is the study performed? The actual scan time is 3-7 seconds (an easy breath hold for almost all patients)
  • 101. LDCT – How is the study performed? • The examination is performed with a low dose protocol using the lowest radiation dose possible to obtain a diagnostic scan. • Radiation dose from a Low Dose CT falls in the range of 0.61 – 1.5 mSv
  • 102. LDCT – How is the study performed? • Radiation dose from a LDCT falls in the range of 0.61 – 1.5 mSv
  • 103. LDCT – How is the study performed? • Radiation dose from a LDCT falls in the range of 0.61 – 1.5 mSv What does that mean?
  • 104. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? – For reference, the background average annual radiation dose in the U.S. is approximately 3.1 mSv – Background radiation dose is affected by terrestrial and celestial sources of background radiation
  • 105. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? – For reference, the background average annual radiation dose in the U.S. is approximately 3.1 mSv – Background radiation dose is affected by terrestrial and celestial sources of background radiation
  • 106. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? • The atmosphere offers some protection from celestial radiation; so living at lower altitude has an intrinsically protective effect and reduces our dose of background radiation.
  • 107. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? • Living at lower altitude results in a lower annual background radiation dose.
  • 108. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? • The difference in annual background radiation dose between living in San Francisco (at sea level) and living in Denver (mile high) is approximately 1.5 mSv
  • 109. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? • The difference in annual background radiation dose between living in San Francisco (at sea level) and living in Denver (mile high) is approximately 1.5 mSv
  • 110. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean?
  • 111. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? •The dose is very low.
  • 112. Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv • What does that mean? •The dose is very low. •The dose is less than background differences between living in Denver and living in San Francisco.
  • 113. LDCT – How is the study interpreted and reported? • We use LungRADS structured reporting and guidelines for recommendations regarding followup and treatment.
  • 114. LDCT – How is the study interpreted and reported? • We use LungRADS structured reporting and guidelines for recommendations regarding followup and treatment.
  • 115. LungRADS • LungRADS was devised along a framework similar to BIRADS, the Breast Imaging reporting system that has been in use for over 20 years.
  • 116. LungRADS • To determine the significance of detected lung nodules and to determine the appropriate surveillance or action needed, LungRADS attends to : • (1) nodule size • (2) nodule consistency • (3) nodule stability
  • 117. LungRADS • To determine the significance of detected lung nodules and to determine the appropriate surveillance or action needed, LungRADS attends to : • (1) nodule size • (2) nodule consistency • (3) nodule stability
  • 118. LungRADS • To determine the significance of detected lung nodules and to determine the appropriate surveillance or action needed, LungRADS attends to : • (1) nodule size • (2) nodule consistency • (3) nodule stability
  • 119. LungRADS • To determine the significance of detected lung nodules and to determine the appropriate surveillance or action needed, LungRADS attends to : • (1) nodule size • (2) nodule consistency • (3) nodule stability
  • 120. LungRADS • (1) nodule size – Larger nodules are more concerning than smaller nodules • Smaller nodules are more likely to be postinflammatory or benign
  • 121. LungRADS • (2) nodule consistency
  • 122. LungRADS • (2) nodule consistency – Solid – Part solid – Non-solid (ground glass) • The more solid a nodule or the larger the solid component of a nodule, the more worrisome the finding
  • 123. LungRADS • (3) nodule stability – Stability is a marker of benignity • Growing or changing nodules or nodules that have newly developed since previous imaging are more concerning
  • 126. LungRADS • (3) nodule stability 20132015 Adenocarcinoma in situ Minimally invasive adenocarcinoma
  • 127. LungRADS • LungRADS categorizes the findings of a LDCT lung screening examination with a numeric value (0 to 4, increasing in level of concern) with a corresponding established recommendation for followup imaging or other action.
  • 129. Complete Chart including nodule size, consistency and stability
  • 131. LungRADS • CATEGORY 0: “INCOMPLETE”
  • 132. LungRADS • CATEGORY 0: “INCOMPLETE” – Images degraded by motion – The region of interest is not entirely included
  • 133. LungRADS • CATEGORY 0: “INCOMPLETE” – Images degraded by motion – The region of interest is not entirely included PATIENT NEEDS TO BE RECALLED FOR COMPLETION OF IMAGING
  • 134. LungRADS • CATEGORY 1: “NEGATIVE”
  • 135. LungRADS • CATEGORY 1: “NEGATIVE” – EITHER NO LUNG NODULES OR ONLY DEFINITELY BENIGN NODULES (granulomas, hamartomas, etc.)
  • 136. LungRADS • CATEGORY 1: “NEGATIVE” – EITHER NO LUNG NODULES OR ONLY DEFINITELY BENIGN NODULES (granulomas, hamartomas, etc.) FOLLOWUP LDCT IN ONE YEAR
  • 137. LungRADS • CATEGORY 2: “BENIGN”
  • 138. LungRADS • CATEGORY 2: “BENIGN” – VERY SMALL NODULES (<6mm) OR NODULES THAT ARE KNOWN TO BE STABLE OR DECREASING IN SIZE
  • 139. LungRADS • CATEGORY 2: “BENIGN” – SMALL LUNG NODULES AND NODULES WITH PROVEN STABILITY FOLLOWUP LDCT IN ONE YEAR
  • 140. LungRADS • CATEGORY 3: “PROBABLY BENIGN”
  • 141. LungRADS • CATEGORY 3: “PROBABLY BENIGN” – SLIGHTLY LARGER BUT STILL SMALL NODULES WITHOUT PROVEN STABILITY
  • 142. LungRADS • CATEGORY 3: “PROBABLY BENIGN” – SLIGHTLY LARGER BUT STILL SMALL NODULES WITHOUT PROVEN STABILITY SHORTER TERM FOLLOWUP LDCT IN 6 MONTHS To establish stability or regression and exclude lesion growth
  • 143. LungRADS • CATEGORY 4: “SUSPICIOUS”
  • 144. LungRADS • CATEGORY 4: “SUSPICIOUS” – LARGER NODULES OR SUSPICIOUS APPEARING NODULES WITHOUT PROVEN STABILITY
  • 145. LungRADS • CATEGORY 4: “SUSPICIOUS” – LARGER NODULES OR SUSPICIOUS APPEARING NODULES WITHOUT PROVEN STABILITY 3-MONTH CT FOLLOWUP, ADDITIONAL CHARACTERIZATION WITH PET-CT OR TISSUE SAMPLING (BRONCHOSCOPY, PERCUTANEOUS NEEDLE BIOPSY, EXCISIONAL BIOPSY, VATS, MEDIASTINOSCOPY)
  • 146. LungRADS • CATEGORY 4: “SUSPICIOUS” The vast majority of these findings are followed with imaging alone.
  • 147. LungRADS • CATEGORY 4: “SUSPICIOUS” The vast majority of these findings are followed with imaging alone. Only about 1% of initial CT lung screens result in a need for tissue sampling.
  • 148. What Constitutes a NEGATIVE Screen?
  • 149. What Constitutes a NEGATIVE Screen? • Any LDCT for which annual LDCT followup is recommended
  • 150. What Constitutes a NEGATIVE Screen? • Any LDCT for which annual LDCT followup is recommended • LungRADS categories 1 and 2 • “Negative” or “Benign”
  • 151. What Constitutes a NEGATIVE Screen? • Any LDCT for which annual LDCT followup is recommended • LungRADS categories 1 and 2 • “Negative” or “Benign” • >90% of all initial screens
  • 152. What Constitutes a Positive Screen?
  • 153. What Constitutes a Positive Screen? • Any LDCT finding for which follow up other than annual screening is recommended.
  • 154. What Constitutes a Positive Screen? –LungRADS 3 “Probably Benign” • (6 mos f/u LDCT) • ~5% of initial screens –LungRADS 4 “Suspicious” • (3 mos f/u, PET-CT, and/or tissue sampling) • ~4% total, most being followed with LDCT in 3 mos or with CT or PET-CT
  • 155. What Constitutes a Positive Screen? –LungRADS 3 “Probably Benign” • (6 mos f/u LDCT) • ~5% –LungRADS 4 “Suspicious” • (3 mos f/u CT, PET-CT, and/or tissue sampling) • ~4% of initial screens, most being followed with imaging
  • 156. What Constitutes a Positive Screen? –LungRADS 4 “Suspicious” • (3 mos f/u, PET-CT, and/or tissue sampling) • ~4% total, most being followed with LDCT in 3 mos or with CT or PET-CT • Only approximately 1% of initial screenings result in a recommendation for tissue sampling. The rest are further evaluated with imaging alone.
  • 157. Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening Established by ACR and STR Designated Lung Screening Center under CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool Participate in a Lung Cancer Screening Registry Follow patient selection guidelines
  • 158. Practice Parameters were established by agreement between many interested organizations
  • 159. Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening Screening should be performed at a designated Lung Screening Center under a CT accreditation program that specifies CT equipment, imaging protocols, and experience and skills of the interpreting radiologists. LungRADS structured reporting and management tool should be employed Participate in a Lung Cancer Screening Registry Follow patient selection guidelines
  • 160. Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool should be employed for reporting and decision making. Participate in a Lung Cancer Screening Registry Patient selection guidelines should be followed
  • 161. Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool The screening center should participate in a Lung Cancer Screening Registry Patient Selection guidelines should be followed
  • 162. Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool The screening center should participate in a Lung Cancer Screening Registry Patient selection guidelines should be followed
  • 163. LDCT: Referring Provider What are the roles of the referring provider?
  • 164. LDCT: Referring Provider • Complete an order for LDCT • Affirm the patient’s eligibility (usually a checkbox form) • Provide shared decision making with the patient prior to the first screening LDCT
  • 165. LDCT: Referring Provider • Complete an order for LDCT • Affirm the patient’s eligibility (usually a checkbox form) • Provide shared decision making with the patient prior to the first screening LDCT
  • 166. LDCT: Referring Provider • Complete an order for LDCT • Affirm the patient’s eligibility (usually a checkbox form) • Provide shared decision making with the patient prior to the first screening LDCT
  • 167. LDCT: Shared Decision Making • What is shared decision making?
  • 168. LDCT: Shared Decision Making • Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT. Benefits: • Detecting early lung cancer in it’s treatable stages. • Detecting other unknown treatable findings • Encouragement of smoking cessation
  • 169. LDCT: Shared Decision Making • Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT. Benefits: • Detecting early lung cancer in it’s treatable stages. • Detecting other treatable findings • Encouragement of smoking cessation
  • 170. LDCT: Shared Decision Making • Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT. Benefits: • Detecting early lung cancer in it’s treatable stages. • Detecting other treatable findings • Encouragement of smoking cessation
  • 171. LDCT: Shared Decision Making • Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT. Benefits: • Detecting early lung cancer in it’s treatable stages. • Detecting other treatable findings • Encouragement of smoking cessation
  • 172. LDCT: Shared Decision Making Potential Harms: •Radiation exposure (as little as possible -- similar to the difference between living in SF versus Denver for a year •False positive results – findings that require additional follow up, imaging, or tissue sampling that do not eventually prove to be lung cancer.
  • 173. LDCT: Shared Decision Making Potential Harms: •Radiation exposure (as little as possible -- similar to the difference between living in SF versus Denver for a year •False positive results – findings that require additional follow up, imaging, or tissue sampling that do not eventually prove to be lung cancer.
  • 174. LDCT: Shared Decision Making Potential Harms: •Overdiagnosis – the phenomenon of detecting a lung cancer that is so indolent that it would not go on to result in lung cancer death if it remained undetected and untreated.
  • 175. LDCT: Shared Decision Making Several excellent tools provide guidance regarding shared decision making and provide patients with useful information regarding potential benefits and harms of lung cancer screening with LDCT
  • 176. LDCT: Shared Decision Making Should I Screen? http://www.shouldiscreen.com/ Web based decision making aid with a risk calculator that patients can use to determine their risk of developing lung cancer based on factor including age, smoking history, personal cancer history, family lung cancer history, history of COPD or pulmonary fibrosis
  • 177. LDCT: Shared Decision Making Should I Screen? http://www.shouldiscreen.com/ Web based decision making aid that describes lung cancer, lung cancer screening, the dangers of smoking and provides a risk calculator that patients can use to determine their risk of developing lung cancer based on their age and personal risk factor profile.
  • 180. LDCT: Shared Decision Making http://www.nccn.org/patients/guidelines/lung_s creening/ Web based booklet provided by the National Comprehensive Cancer Network that can be navigated online or printed. Provides patients with educational materials to help inform them of the potential benefits and harms of lung cancer screening with LDCT
  • 181. LDCT: Shared Decision Making http://www.nccn.org/patients/guidelines/lung_s creening/ Web based booklet provided by the National Comprehensive Cancer Network that can be navigated online or printed. Provides patients with educational materials to help inform them of the potential benefits and harms of lung cancer screening with LDCT
  • 182. NCCN
  • 183. What’s do we do next? • Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them • Refer appropriate patients for LDCT at a reputable, accredited screening facility. • Stay informed.
  • 184. What’s do we do next? • Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them • Refer appropriate patients for LDCT at a reputable, accredited screening facility. • Stay informed.
  • 185. What’s do we do next? • Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them • Refer appropriate patients for LDCT at a reputable, accredited screening facility. • Stay informed.
  • 186. What’s do we do next? • Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them • Refer appropriate patients for LDCT at a reputable, accredited screening facility. • Stay informed. The landscape is changing daily, and there new information and new ideas are emerging all the time.
  • 187. Low Dose CT Lung Cancer Screening Update 2015 Clay H. Napper, M.D.
  • 189.
  • 190.
  • 191. Stay Informed - Changing Landscape • Journal of the National Cancer Institute – October 19, 2015 (hot off the press) “CT lung cancer screening may benefit even those with fewer than 30 pack- years of smoking history.” After reviewing the “records of more than 30,000 smokers and former smokers who participated in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) and had smoking histories ranging from 20 to 29 pack-years,” researchers found that “their risk of developing cancer was very similar to that of patients eligible for screening in the National Lung Screening Trial (NLST), which focused on individuals with smoking histories of 30 pack-years or more.”
  • 192. Radiographic Differential Diagnosis • Post-inflammatory granuloma (80%) • Benign neoplasm (e.g. hamartoma) • Pulmonary AVM • Solitary lung metastasis • Primary lung cancer • Other miscellaneous nodules (nodular sarcoid, rheumatoid nodule, pulmonary-renal syndrome granuloma, bronchogenic cyst, hematoma, abscess, others…)
  • 193. • Solitary pulmonary nodule • Rates of Growth – Volume doubling time for most bronchial /lung carcinomas is 1-18 months. – A 26% increase in diameter is equivalent to a doubling in volume • 5 mm --> 6.3 mm --> 7.7 mm • 10 mm --> 12.6 mm --> 15 • For small lesions, growth may not be perceptible until the tumor has doubled or even quadrupled in volume
  • 194. • Solitary pulmonary nodule • Rates of Growth – Volume doubling time for most bronchial/lung carcinomas is 1-18 months. – Volume doubling is equivalent to only a 26% increase in diameter For small lesions, growth may not be perceptible until the tumor has doubled or even quadrupled in volume • 5 mm --> 6.3 mm --> 7.7 mm • 10 mm --> 12.6 mm --> 15
  • 195. Applications • Solitary pulmonary nodule: Percutaneous BX • Risks of Percutaneous Biopsy – Pneumothorax 20-25% – Chest tube required 5-10% – Hemoptysis 5% – Malignant seeding 0.01% – Air embolism 0.1% – Death 0.2%