Standardized Reporting/Lung-RADS

Transcription

1 Standardized Reporting/Lung-RADS Ella A. Kazerooni, MD ACR & Lung Cancer Screening Standardized Reporting / Lung-RADS Ella A. Kazerooni, M.D. Chair, ACR Committee on Lung Cancer Screening Professor & Director Cardiothoracic Radiology Associate Chair for Clinical Affairs University of Michigan 1) Guidelines: ACR STR Practice Parameter 2) Structured Reporting: 3) Accreditation: ACR Lung Cancer Screening Center Designation 4) Oversight: ACR National Radiology Data Registry ACR & Lung Cancer Screening Released April ) Guidelines: ACR STR Practice Parameter 2) Structured Reporting: 3) Accreditation: ACR Lung Cancer Screening Center Designation 4) Oversight: ACR National Radiology Data Registry Structured reporting and management tool for lung cancer screening CT interpretation Practice audit component Safety/Resources/LungRADS Structured reporting and management Provides a common lexicon/definitions Standardizes practice among radiologists for communicating with ordering providers Facilitates benchmarking and comparison Radiologist, practice/system, geography 0-4 Categories 2 Modifiers: S - Clinically Significant or Potentially Clinically Significant Findings (non lung cancer) C - Prior diagnosis of lung cancer who return to screening Facilitates practice audit Total # of screens Distribution of screens across categories Positive screen rate, cancer diagnosis rate PPVs

2 Descriptor Descriptor Primary Incomplete - 0 Negative No nodules & definitely benign nodules 1 Benign Appearance or Behavior Nodules with a very low likelihood of becoming a clinically active cancer due to size or lack of growth 2 Descriptor Descriptor Primary Incomplete - 0 Negative No nodules & definitely benign nodules 1 Benign Nodules with a very low likelihood Appearance or of becoming a clinically active cancer due to size or lack of 2 Behavior growth Management Additional lung cancer screening CT images and/or comparison to prior chest CT examinations is needed Continue annual screening with LDCT in 12 months Probably Benign Suspicious Probably benign finding(s) - short term follow up suggested; includes nodules with a low likelihood of becoming a clinically active cancer Findings for which additional diagnostic testing and/or tissue sampling is recommended 3 4A 4B Probably Benign Suspicious Probably benign finding(s) - short term follow up suggested; includes nodules with a low likelihood of becoming a clinically active cancer Findings for which additional diagnostic testing and/or tissue sampling is recommended 3 6 month LDCT 4A 4B 3 month LDCT; PET/CT may be used chest CT with or without contrast, PET/CT and/or tissue sampling depending on the *probability of malignancy and comorbidities. Nodule size baseline, growth v stability Nodule consistency solid, part solid, non solid (aka ground glass nodule) calcification, fat Benign & benign behavior vs. clinically active cancer (what is cancer?) Reduces false positives from > 1 in 4, to 1 in 10 Classifying Screen-Detected Lung Nodules solid part solid non solid aka GGO or GGN Fundamental question: What is a positive screen? NLST: Positive CT Screen Definition Nodule 4 mm Independent of nodule consistency Positive screen rates: 27.3% baseline 27.9% T1 screen 16.8% T2 screen

3 Lung Cancer CT Screening & False Positives 40% of NLST subjects had at least one FP over 3 years Uncertainty about best management protocol for FPs Among patients with a positive screen who underwent a diagnostic procedure, 1.4% experienced a complication NLST: Diagnostic Follow-up of Positive Screens LDCT CXR T0 (%) T1 (%) T2 (%) Total (%) T0 (%) T1 (%) T2 (%) Total (%) Total positives 7191 (100%) 6901 (100%) 4054 (100%) 18,146 (100%) 2387 (100%) 1482 (100%) 1174 (100%) 5043 (100%) Confirmed lung cancer 270 (3.8%) 168 (2.4%) 211 (5.2%) 649 (3.6%) 136 (5.7%) 65 (4.4%) 78 (6.6%) 279 (5.5%) Non-invasive Procedures T0 (%) T1 (%) T2 (%) Total (%) T0 (%) T1 (%) T2 (%) Total (%) Imaging Exam 81.1% 37.4% 51.3% 57.9% 85.6% 66.5% 78.9% 78.4% CXR 18.2% 9.1% 16.6% 14.4% 36.9% 26.2% 31.8% 32.6% Chest CT 73.1% 30.4% 41.1% 49.8% 65.8% 51.2% 62.0% 60.6% PET or PET-CT 10.3% 5.2% 10.0% 8.3% 7.6% 7.2% 9.8% 8.0% Invasive Procedures T0 (%) T1 (%) T2 (%) Total (%) T0 (%) T1 (%) T2 (%) Total (%) Percutaneous FNA/Core 2.2% 1.1% 2.4% 1.8% 3.5% 2.5% 4.5% 3.5% Bronchoscopy 4.6% 2.6% 4.8% 3.8% 4.6% 3.8% 5.4% 4.5% Surgical procedure(s) 4.2% 2.9% 5.6% 4.0% 5.2% 3.5% 5.8% 4.8% Mediastinoscopy 0.9% 0.5% 0.6% 0.7% 0.9% 0.8% 1.7% 1.1% VATS 1.2% 0.8% 2.5% 1.3% 0.9% 0.8% 1.7% 1.1% Thoracotomy 2.8% 2.2% 4.2% 2.9% 4.1% 3.0% 3.8% 3.7% NLST Investigators; NEJM 2011;365: Size Threshold for a Positive Lung Cancer Screening CT effect of alternative thresholds for defining a positive result on the rates of positive results and cancer diagnoses Size Threshold for a Positive Lung Cancer Screening CT 21,136 individuals with baseline CT performed between 2006 and 2010 Size (+) Screen Rate Work Up Reduction 5 mm 16.0% 6 mm 10.2% 36% 7 mm 7.1% 56% 8 mm 5.1% 68% 9 mm 4.0% 75% 9 month delay in cancer dx 0%, 5%, 5.9%, 6.7% Non Solid Nodules & 2011 IASLC/ATS/ERS International Multidisciplinary Classification of Lung Adenocarcinoma Preinvasive Lesions: Atypical adenomatous hyperplasia (AAH) localized small proliferation of atypical Type II pneumocytes and/or Clara cells lining the alveolar walls and respiratory bronchioles Adenocarcinoma in situ (AIS) lepidic growth complete resection achieves 100% disease-specific survival Non Solid Nodules & : 2011 IASLC/ATS/ERS International Multidisciplinary Classification of Lung Adenocarcinoma Minimally invasive adenocarcinoma (MIA) lepidic the largest dimension does not invade lymphatics, blood vessels, or pleura contains no necrosis complete resection achieves nearly 100% disease-specific survival Invasive adenocarcinoma

4 Non Solid Nodules & : Management of ground-glass opacities: should all pulmonary lesions with ground-glass opacity be surgically resected? Y Kobayashi & T Mitsudomi; Translational Lung Clinical Research 2013;2(5) Inclusion Criteria observation without treatment in prior 6 months 120 nodules; 32 surgically resected histological diagnoses: 3 AAH, 12 AIS, 11 MIA, 6 invasive adenocarcinoma volume-doubling time of pure GGOs ranges from approximately days Non Solid Nodules & : volume-doubling time (VDT) of pure GGOs ranges from approx 600 to 900 days 3 Descriptor Findings Management Negative No nodules and definitely benign nodules 1 no lung nodules nodule(s) with specific calcifications: complete, central, popcorn, concentric rings and fat containing nodules Descriptor Findings Management solid nodule(s): Nodules with a very Benign low likelihood of Appearance or becoming a clinically active cancer due to Behavior size or lack of growth 2 solid nodule(s): < 6 mm new < 4 mm part solid nodule(s): < 6 mm total diameter on baseline screening non solid nodule(s) (GGN): < 20 mm OR Continue annual screening with LDCT in 12 months Probably Benign Probably benign finding(s) - short term follow up suggested; includes nodules with a low likelihood of becoming a clinically active cancer 3 new 4 mm to < 6 mm part solid nodule(s) solid component < 6 mm OR new < 6 mm total diameter 6 month LDCT baseline CT or new 4 Descriptor Findings Management solid nodule(s): Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4A 4B 4X growing < 8 mm OR new 6 to < 8 mm part solid nodule(s: with a new or growing < 4 mm solid component endobronchial nodule solid nodule(s) part solid nodule(s) with: 3 or 4 nodules with additional features or imaging findings that increases the suspicion of malignancy 3 month LDCT; PET/CT may be used solid component chest CT with or without contrast, PET/CT and/or tissue sampling depending on the *probability of malignancy and comorbidities. PET/CT may be used when there component 1) Negative screen: does not mean that an individual does not have lung cancer 2) Size: nodules should be measured on lung windows and reported as the average diameter rounded to the nearest whole number; for round nodules only a single diameter measurement is necessary 3) Size Thresholds: apply to nodules at first detection, and that grow and reach a higher size category 4) Growth: an increase in size of > 1.5 mm 5) Exam : each exam should be coded 0-4 based on the nodule(s) with the highest degree of suspicion 6) Exam Modifiers: S & C modifiers may be added to the 0-4 category

5 7) Lung Cancer Diagnosis: Once a patient is diagnosed with lung cancer, further management (including additional imaging such as PET/CT) may be performed for purposes of lung cancer staging; this is no longer screening 8) Practice audit definitions: a negative screen is defined as categories 1 and 2 a positive screen is defined as categories 3 and 4 9) 4B Management: predicated on the probability of malignancy based on patient evaluation, patient preference and risk of malignancy radiologists are encouraged to use the McWilliams et al assessment tool when making recommendations 10) 4X: nodules with additional imaging findings that increase the suspicion of lung cancer, such as spiculation, GGN that doubles in size in 1 year, enlarged lymph nodes etc 11) Nodules with features of an intrapulmonary lymph node should be managed by mean diameter and the 0-4 numerical category classification 12) 3 and 4A nodules that are unchanged on interval CT should be coded as category 2, and individuals returned to screening in 12 months 13) LDCT: low dose chest CT 2180 consecutive high-risk patients undergoing clinical CT screening between 1/ /2014 reclassified using LungRADS Lung-RADS: Reduced positive screen rate from 27.6% to 10.6% No false negatives in the 152 patients with >12-month followup reclassified as benign Increased PPV for malignancy from 6.9% to 17.3% Data In Submission Performance in the NLST: A Retrospective Assessment Reclassified NLST CT screening exams using LungRADS 26,722 LDCT arm subjects (26,309 baseline; 48,671 post-baseline BASELINE POST BASELINE LungRADS (NLST) LungRADS (NLST) FPR (1-Specificity) 12.9% (26.6%) 5.3% (27.4%) Sensitivity 86.1% (93.8%) 78.6% (94.4%) PPV 6.9% (3.8%) 10.9% (2.4%) Data In Submission Performance in the NLST: A Retrospective Assessment False negative LungRADS screens were nodules with no growth and/or pure nonsolid nodules (5 year survival 64% TPs vs. 73% FNs) Compared to the original NLST criteria FPRs with LungRADS were ½ at baseline and ¼ post-baseline Sensitivity was 8% and 15% lower at baseline and postbaseline PPV was 2-3 fold higher for LungRADS ACR Lung Cancer Screening Advocacy

6 ACR & Lung Cancer Screening 1) Guidelines: ACR STR Practice Parameter 2) Structured Reporting: 3) Accreditation: ACR Lung Cancer Screening Center Designation 4) Oversight: ACR National Radiology Data Registry Standardized Reporting / Lung-RADS Ella A. Kazerooni, M.D. Chair, ACR Committee on Lung Cancer Screening Professor & Director Cardiothoracic Radiology Associate Chair for Clinical Affairs University of Michigan