CT Small Lung Nodule Biomarker Ctte

Co-chairs: Samuel G. Armato, III, PhD; David Gierada, MD; James L. Mulshine, MD

Secretary: Julie Lisiecki

• Roster

Meetings

Recent Call Summaries:

• June 14, 2018
• April 19, 2018
• April 5, 2018
• March 8, 2018

Small Lung Nodule BC Call Summaries Archive

Profile Development

Small Lung Nodule Assessment in CT Screening Profile

Small Lung Nodule Profile

• QIBA Small Lung Nodule Profile Draft 2018.06.15
• QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet Draft 2018.06.15
• QIBA Small Lung Nodule Profile Draft 2018.02.11
• QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet Draft 2018.02.11
• QIBA Small Lung Nodule Profile Draft 2017.11.15

Status - Final Review in progress

• QIBA Small Lung Nodule Profile Draft 2017.10.31
• QIBA Lung Nodule Profile Comment Response 2017.10.07
• QIBA Lung Nodule Profile Draft 2017.09.27

Supporting documents:

• Ref3_SPIE 2017 Proceedings
• Ref5_Avila_et al_IWCLC Tape QA Abstract
• Ref6_Avila_etal_WCTI Hot Topic Abstract
• Ref7_Avila_et al_A Novel Ultra Low Cost CT Image Quality Measurement Dev
• Ref8_Avila_et al_Automatic Estimation of Measurement Error on CT Imaging

• QIBA Lung Nodule Profile Draft 2017.08.02

• Comments on mid-May draft from Kevin 2017.06.06

Status - Public Comment complete

• QIBA Profile: CT Lung Nodule Assessment in Screening Public Comment 2016.06.01 (ended Sept 2016)

• Spreadsheet: Small Nodule Profile References_Accuracy
• Spreadsheet: Small Nodule Profile References_Precision

Past

• Archived Versions of Profile-related documents.

Reference Materials

• Henschke CI, Yankelevitz DF, Yip R, Archer V, Zahlmann G, Krishnan K, Helba B, Avila R, Tumor volume measurement error using computed tomography imaging in a phase II clinical trial in lung cancer. J Med Imaging (Bellingham). 2016 Jul;3(3):035505. Journal of Medical Imaging

Conformance Materials

The QIBA CT Small Lung Nodule Profile refers to several online resources that are needed to achieve conformance. Links to these resources can be found here.

Clinical Site Conformance

Verified Vendor Systems

• QIBA Verified Conformant CT Scanners: All FDA approved CT scanners may be used at this time.
• QIBA Verified Conformant Nodule Analysis Software: All FDA approved Nodule Analysis Software may be used at this time.

Phantom Data Upload Site

• Link to QIBA Data Upload Site For Clinical Sites

Small Lung Nodule Online Calculator

• QIBA Small Lung Nodule Online Calculator

CT Scanner Vendor Conformance

Phantom Data Upload Site

• Link to QIBA Data Upload Site For CT Scanner Vendors

http://services.accumetra.com/CTLX1report.php

Software Analysis Vendor Conformance

Phantom Nodule Dataset

• Phantom Nodule Dataset V1
• Link to QIBACTSLN-PhantomNoduleDatasetLocationsV1.xls
• Link to QIBACTSLN-PhantomNoduleDatasetMeasureReportingFileV1.xls

Clinical Nodule Dataset

• Clinical Nodule Dataset V1
• Link to QIBACTSLN-ClinicalNoduleDatasetLocationsV1.xls
• Link to QIBACTSLN-ClinicalNoduleDatasetMeasureReportingFileV1.xls

Reporting Data Upload Site

• Link to QIBA Data Upload Site For Software Analysis Vendors