Implementation & optimization of a lung cancer screening CT program. Presented by Izabella Barreto at the 2016 Florida AAPM Chapter Meeting

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Implementation & optimization of a lung cancer screening CT program Presented by Izabella Barreto at the 2016 Florida AAPM Chapter Meeting Izabella Barreto, Nathan Quails, Catherine Carranza, Nathalie Correa, Michael Bickelhaup, Tan Lucien Mohammed, Nupur Verma, Lynn Rill, Manuel Arreola Department of Radiology University of Florida College of Medicine Gainesville, FL MOTIVATION 1.8 million new lung cancer cases worldwide in 2012 1.59 million lung cancer deaths worldwide in 2012 International Agency for Research on Cancer. GLOBOSCAN 2012, World Health Organization 1

MOTIVATION 1.8 million LUNG CANCER new lung cancer cases is the worldwide most common in 2012 TYPE OF CANCER & CANCER DEATH 1.59 million lung cancer deaths worldwide in 2012 in the world International Agency for Research on Cancer. GLOBOSCAN 2012, World Health Organization LUNG CANCER IN THE UNITED STATES Second most common cancer in the US Leading cause of cancer related deaths in the US National Cancer Institute. SEER 18 2006 2012. 2

RISK FACTORS Lung cancer is also the most preventable form of cancer Cigarette smoking is responsible for more than 80% of lung cancers Other risk factors: Exposure to secondhand smoke, radon, asbestos, radiation, air pollution SURVIVAL RATE 5 year survival rate of 17.4% Compared to 90.3% for breast cancers and 99.7% for prostate cancers National Cancer Institute. SEER 18 2006 2012. 3

LUNG CANCER AT STAGE OF DIAGNOSIS Percent of Cases 5 Year Relative Surival 57 PERCENT (%) 16 22 LOCALIZED REGIONAL DISTANT STAGE AT DIAGNOSIS National Cancer Institute. SEER 18 2006 2012. LUNG CANCER AT STAGE OF DIAGNOSIS Percent of Cases 5 Year Relative Surival 54.8 57 PERCENT (%) 16 22 27.4 4.2 LOCALIZED REGIONAL DISTANT STAGE AT DIAGNOSIS National Cancer Institute. SEER 18 2006 2012. 4

LUNG CANCER SCREENING It is crucial to detect lung cancer as early as possible to increase chances for treatment and survival. Many studies have attempted to identify an effective screening test for detecting early stage lung cancer in asymptomatic patients with the goal of decreasing mortality LUNG CANCER SCREENING Chest radiography Used as a lung cancer screening tool for several decades Studies showed no significant improvement in lung cancer mortality Multidetector Computed Tomography Improved spatial resolution & increased scan speed Inherent contrast in lung parenchyma Cross sectional data acquisition and display Enables visualization of more subtle abnormalities Several studies showed that low dose CT (LDCT) screening detects more early stage lung cancers than chest radiography However, none addressed the effects of LDCT screening on lung cancer mortality 5

2002 Assigned 53,439 participants current or former heavy smokers who were 55 74 year old to receive annual screenings for 3 years with low dose CT (LDCT) or standard chest x ray (CXR) Screening took place from 8/2002 9/2007, patients were followed until 2009 2011 Results found 20% fewer lung cancer deaths in participants screened with LDCT than with CXR 2013 The US Preventive Services Task Force (USPSTF) Recommended annual lung cancer screening with LDCT 2015 Centers for Medicare & Medicaid Services (CMS) Approved coverage of annual lung cancer screening with LDCT 2015 American College of Radiology (ACR) Lung Cancer Screening Registry (2015) Designated Lung Cancer Screening Center (2014) National Lung Screening Trial Research Team. NEJM. 2011 REQUIREMENTS FOR REIMBURSEMENT Patient eligibility: Asymptomatic Age: 55 77 years of age Current smokers or quit within 15 years 30 pack year smoking history Must receive a written order for LDCT lung cancer screening 6

REQUIREMENTS FOR REIMBURSEMENT Radiology imaging facility eligibility: Makes available smoking cessation interventions Screening read by thoracic radiologists with >300 chest CT interpretations in the past 3 years Utilizes a standardized lung nodule reporting system ACR Lung Reporting and Data System (Lung RADS TM ) Collects and submits data to a CMS approved registry ACR Lung Cancer Screening Registry (LCSR) Provide LDCT with CTDI vol 3.0 mgy for standard size patient (5 7, 155 lbs) with modified CTDI vol for smaller/larger patients REVIEW OF OUR SCREENING PROGRAM 3/1/15: Radiology department implemented lung cancer screening with LDCT Lead by thoracic radiologists and CT supervisors 5/10/15: Physics investigated LCS protocol in a CT scanner Findings: Protocol called low dose chest CT Not specific to lung cancer screening Protocol CTDI vol ~ 10 mgy Dose too high Standard deviation (SD) image quality noise index Set to 12.5 SD Same as standard chest protocol Physics informed CT supervisor & changed protocol s noise index to 19 SD 7

RETROSPECTIVE ANALYSIS 11/20/15: Physics submitted IRB application Retrospective review of patient doses for 8 months of screening 122 patients examined with lung cancer screening CT Between 3/1/15 11/20/15 11/30/15 1/15/16: Using a PACS image viewer, recorded: CT scanner model Scan protocol (kvp, mas, SD) Scanner reported dose metrics (CTDI vol, DLP) Patient size (measured diameter) CT SCANNERS USED Iterative Reconstruction Tube Current Modulation Siemens Sensation 16 Siemens Sensation 16 Toshiba Aquilion 16 Toshiba Aquilion ONE Toshiba Aquilion PRIME 8

CTDI VOL OF 122 EXAMS CTDI vol 35 30 25 20 15 10 5 Toshiba AQ 16 Toshiba AQ 16 Toshiba AQ 16 Toshiba AQ ONE Toshiba AQ ONE Toshiba protocols produced too high dose Toshiba AQ 16 0 Mar Apr May Jun Jul Aug Sep Oct Nov Study Date AAPM s CTDI vol upper limits for: LARGE PATIENT AVERAGE PATIENT SMALL PATIENT CTDI VOL OF ALL EXAMS AFTER 5/10/15 14 12 10 Toshiba CT Scanner Siemens CT Scanner Toshiba AQ 16 SD=15 (No AIDR-3D) CT Technologist stated LCS exams are rarely routed to Toshiba AQ16 due to lack of iterative reconstruction CTDIvol 8 6 4 2 AAPM s CTDI vol upper limits for: LARGE PATIENT AVERAGE PATIENT SMALL PATIENT 0 May-15 Jun-15 Aug-15 Oct-15 Nov-15 Study Date 9

DOSE ADJUSTMENTS FOR PATIENT SIZE Physics measured patient AP & Lateral dimensions On central slice in CT scan Circle of equal area Calculated effective diameter: CTDI VOL VS PATIENT SIZE 6 5 Toshiba CT Scanner Siemens CT Scanner 4 CTDI vol 3 2 1 CTDI vol was nearly constant for patients of varying sizes with Siemens CT scanners 0 20 25 30 35 40 Patient Effective Diameter (cm) 10

DOSE ADJUSTMENTS FOR PATIENT SIZE 1/20/16 Physics presented findings to Radiology Practice Committee (RPC) Thoracic radiologist leading lung cancer screening program Radiology chairman Lead CT supervisor Discussed pros & cons of turning on tube current modulation Discussed noise target levels in Siemens scanners CareDose, Quality Reference mas 1/25/16 Tube current modulation implemented on Siemens CT scanners DOSE ADJUSTMENTS FOR PATIENT SIZE: SIEMENS SENSATION 16 CT SCANNER 11

DOSE ADJUSTMENTS FOR PATIENT SIZE: TOSHIBA & SIEMENS CT SCANNERS 8 7 Toshiba Aquilion ONE Toshiba Aquilion PRIME Siemens Sensation 16 CTDI vol (mgy) 6 5 4 3 2 5.6 mgy is the limit for "large patients" 1 0 20 25 30 35 40 Patient Effective Diameter (cm) SCREENING RISK ASSESSMENT Potential risks from CT need to be considered for the riskbenefit analysis of Lung Cancer Screening CT Scanner reported metrics (CTDI vol, DLP) do not represent true patient doses Requires individual organ dose assessment What typical organ doses are expected from LDCT lung cancer screening exams? 12

HOW CAN WE MEASURE ORGAN DOSES? Simulations with computational phantoms Patient approximations Allows calculations for a variety of patient sizes Radiation source simulations Difficult to model true CT scanner X ray Spectra, bowtie filtration Tube current modulation Iterative reconstruction HOW CAN WE MEASURE ORGAN DOSES? Direct measurements in cadavers Closest representation of a patient undergoing a CT exam Allows measurement inside actual organs Allows image quality assessment for protocol optimization Utilizes a clinical radiation source No simulations or approximations Tube current modulation, iterative reconstruction 13

CAN WE DO THIS? Postmortem Concerns: Livor mortis, Rigor Mortis, Decomposition CADAVER PATIENT We investigated attenuation changes in cadaver versus living patient tissue, assessing changes in µ by looking at HU in various organs. 1000 YES, WE CAN Naturalvariationswereobservedinorgansinbothcadaversand patients groups, due to varying state of health of individuals Lung attenuation differences due to fluid infiltration in cadaver lungs Measuring organ doses in cadaveric subjects is an accurate method for estimating dose in patients undergoing CT examination 14

ACCESS TO POSTMORTEM ORGANS Plastic PVC tubes Inserted into Organs of Interest By radiologist specialized in CT guided biopsies OSL dosimeters Corrected for energy and scatter dependence Sealed in plastic and inserted into affixed PVC tubes Utilizing organ dosimetry methodology developed inhouse by Griglock et al Griglock T, et al. Radiology. 2015 ACCESS TO POSTMORTEM ORGANS 15 OSLDs distributed across the skin 30 OSLDs inserted into tubes secured in organs Example: 8 OSLDs in breasts 8 OSLDs in lungs Organs Number of Dosimeters Skin 15 Thyroid 2 Breast 8 Lung 8 Liver 5 Stomach 2 Colon 2 Ovary 3 15

LUNG CANCER SCREENING CT PROTOCOL Parameter Values CT Scanner Toshiba Aquilion ONE 320 Scan Range Thoracic inlet to bottom of lung Scan type Helical Detector configuration 80 x 0.5 mm Tube Voltage (kvp) 120 Tube Current Modulation SURE Exposure 3D enabled Iterative Reconstruction AIDR 3D enabled ma limits (min max) 10 150 Target Noise Level (SD) 20 Effective mas 32 Rotation Time (s) 0.35 CTDI vol (mgy) 2.2 DLP (mgy cm) 65.9 Soft Tissue Reconstruction 3x3 mm Lung Reconstruction 2x2 mm AAPM s Working Group on Standardization of CT Nomenclature and Protocols MEASURED ORGAN DOSES Small cadaver: 87 lb, 4.36 ft, 22.6 BMI, Deff 21.64 cm, CTDIvol 2.2 mgy Organs located within the scan range are directly exposed by the CT beam: Organs Average Dose (mgy) SD Skin 3.89 0.52 Thyroid 4.16 0.16 Breast 3.56 0.70 Lung 3.28 0.68 Liver 4.19 0.12 Stomach 3.07 0.02 All others are exposed to scattered radiation: Organs Max Dose (mgy) Colon 2.62 Ovary 1.32 16

MEASURED ORGAN DOSES Larger cadaver: Deff 25.63 cm, CTDIvol 5.3 mgy Organs located within the scan range are directly exposed by the CT beam: Organs Average Dose (mgy) SD Skin 7.31 1.23 Thyroid 10.47 Breast 6.56 0.46 Lung 6.01 0.75 Liver 7.33 0.08 Stomach 6.45 0.36 All others are exposed to scattered radiation: Organs Max Dose (mgy) Colon 2.09 Ovary 0.42 Can Lung Cancer Screening CT be conducted with lower dose while still providing acceptable image quality for the purpose of lung cancer screening? 17

PROTOCOL OPTIMIZATION SCAN SETTINGS To assess LCS CT image quality at lower doses: Decreasing kvp (from 120 to 100) Decreasing ma (by increasing SD from 20 to 35) Scan kvp SD Eff mas CTDI vol (mgy) 1 120 20 32 2.2 2 120 25 21 1.5 3 120 35 18 0.8 4 100 20 50 1.9 5 100 25 30 1.5 6 100 35 10 0.7 IMAGE QUALITY ASSESSMENT 2 thoracic radiologists o Blinded to scan techniques Graded: osharp reproduction of the lung parenchyma odiagnostic confidence in assessing lung nodules odiagnostic confidence in assessing lung disease 3 point scale chosen to simplify clinical implementation (1) Unacceptable (2) Borderline acceptable (3) Acceptable 18

IMAGE QUALITY ACCEPTANCE Acceptable Borderline Acceptable Unacceptable 3 2 1 0 1 2 3 4 5 6 Lung Cancer Screening CT Protocol Sharp reproduction of lung detail Confidence in diagnosing nodules Confidence in diagnosing bronchiectasis Protocols with Target Noise Levels of 20 or 25 SD were acceptable Protocols with 35 SD resulted in borderline acceptable scores IMAGE QUALITY ACCEPTANCE Organ doses were measured for the protocols graded with acceptable image quality: Scan kvp SD Eff mas CTDI vol (mgy) 1 120 20 32 2.2 2 120 25 21 1.5 4 100 20 50 1.9 5 100 25 30 1.5 Scan 1 Scan 2 Scan 4 Scan 5 19

ORGAN DOSES 5 120 kvp, 20 SD 120 kvp, 25 SD 100 kvp, 20 SD 100 kvp, 25 SD Organ Dose (mgy) 4 3 2 1 0 19% Dose Reduction 25% Dose Reduction 27% Dose Reduction 21% Dose Reduction 20% Dose Reduction 25% Dose Reduction Skin Thyroid Breast Lung Liver Stomach SI Colon Ovary CONCLUSIONS The AAPM Lung Cancer Screening CT Protocol Produced organ doses 3.07 4.19 mgy Increasing the noise level from 20 to 25 SD Resulted in acceptable image quality Produced organ doses 2.30 3.27 mgy (11 27% organ dose reduction) UF Health implemented these changes to our protocol AAPM implemented these changes as well Future work: Compare patient doses & image quality for patients scanned with the original & new lower dose protocol 20

SUMMARY Lung cancer is the leading cause of cancer related deaths in the United States and cigarette smoking is the most important risk factor NLST is the largest screening trial and shows 20% reduction in mortality LDCT is the only recommended screening test to detect early lung cancer Be mindful of CT dose variation in protocols across scanners: Appropriate use of CT scanners Comprehensive training for technologists Standardized CT protocols Appropriate scan length Tube current modulation Tube potential Iterative reconstruction ACKNOWLEDGEMENTS Physics Manuel Arreola, PhD Lynn Rill, PhD Nathan Quails, BS Catherine Carranza, BS Nathalie Correa Computed Tomography Michael Bickelhaup, ARRT Lori Gravelle, ARRT Sondra Garrett, ARRT Thoracic Imaging Tan Lucien Mohammed, MD Nupur Verma, MD 21

THANK YOU FOR YOUR ATTENTION ORGAN DOSE VS PATIENT SIZE Organ dosimetry repeated in 10 cadavers Ranging from underweight to obese weight class Same: Scanner: Toshiba Aquilion ONE Scan range: Thoracic inlet to bottom of lungs Scan parameters modified: Varying levels of ma Filtered backprojection Iterative reconstruction 65, 80, 100, 160 detector channels 22

25 Chest organ doses measured in 10 cadavers 20 Organ Dose (mgy) 15 10 5 Breast Lung Liver Stomach SSDE 0 20 22 24 26 28 30 32 34 Cadaver Effective Diameter (cm) 3 CTDI to organ dose conversion coefficients Conversion Coefficient 2 2 1 1 Breast Lung Liver Stomach SSDE 0 20 22 24 26 28 30 32 34 Cadaver Effective Diameter (cm) 23

3 CTDI to organ dose conversion coefficients Conversion Coefficient 2 2 1 1 Breast Lung Liver Stomach SSDE 0 20 22 24 26 28 30 32 34 Cadaver Effective Diameter (cm) NLST risks of screening False Positives: LDCT had a high false positive rate (96.4%) 18,146 positive tests Only 649 were confirmed to be lung cancer Other 17,497 were benign intrapulmonary lymph nodes or noncalcified granulomas Only 2.5% of positive screens required invasive diagnostic procedures CXR had 94.5% false positive rate 5,043 positive tests Only 279 were confirmed to be lung cancer Overdiagnosis: Estimated to be at about 10% Results from detection of cancers that never would have become symptomatic Radiation induced cancers: estimated <1% of cases Incidental findings 7.5% were clinically significant Coronary artery calcifications, emphysema, pulmonary fibrosis, bronchiectasis, benign tumors Psychological stress / / 24

CTDI vol Specifications American College of Radiology (ACR) CTDI vol must be 3 mgy for standard size patient American Association of Physicists in Medicine (AAPM) CTDI vol must be 3 mgy for standard size patient Other sizes: IMAGE RECONSTRUCTION 8 different axial image reconstructions: o Standard Body Axial (FC18) o Lung Low Dose (FC55) o Lung Sharp (FC86) o Lung High Resolution CT (FC86) 1 mm & 3 mm 1 mm & 3 mm 1 mm & 3 mm 1 mm & 3 mm Chief of Thoracic Imaging oblinded to reconstruction parameters oidentified preferred reconstruction for LCS 25

IMAGE RECONSTRUCTION Soft Tissue: o1 mm image appeared too noisy opreferred 3 mm reconstruction Lung: o 3 mm image lacked detail o Better lung detail with 1 mm slices odespite increase in noise o High Resolution CT algorithm looked too noisy o Lung Low Dose algorithm lacked detail Ideal reconstruction settings: o3 mm Standard Body Axial algorithm o1 mm Lung Sharp algorithm Lung Reporting and Data System (Lung RADS TM ) Standardized system for identification, classification & reporting of lung nodules Category 0: Incomplete Additional imaging needed Category 1: Negative Continue annual LDCT screening Category 2: Benign Continue annual LDCT screening Category 3: Probably benign LDCT in 6 months Category 4A: Suspicious LDCT in 3 months PET/CT if 8 mm solid component exists Category 4B: Suspicious Chest CT w/wo contrast PET/CT and/or biopsy 26

Lung Cancer Screening Registry First lung cancer screening registry approved by CMS Launched in 2015 Participant responsibilities Furnish data for a twelve month period Provide data for all eligible patients and exams to ACR Submit follow up information A Facility Administrator should be identified 27