Difference between revisions of "CT Small Lung Nodule Biomarker Ctte"

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Co-chairs: Samuel G. Armato, III, PhD; David Gierada, MD; James L. Mulshine, MD  
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Co-chairs: Artit Jirapatnakul, PhD; James L. Mulshine, MD; Kyle J. Myers, PhD
 
 
Secretary: Julie Lisiecki
 
  
 
* [http://tinyurl.com/QIBA-CT-SLN-Roster Roster]
 
* [http://tinyurl.com/QIBA-CT-SLN-Roster Roster]
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'''Recent Call Summaries:'''
 
'''Recent Call Summaries:'''
  
*[[Media:06 14 2018 QIBA CT Small Lung Nodule BC-FINAL.pdf|June 14, 2018]]
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*[[Media:2023 12-19 QIBA CT SLN BC-FINAL.pdf| December 19, 2023]]
*[[Media:04 19 2018 QIBA CT Small Lung Nodule BC-FINAL-JM.pdf|April 19, 2018]]
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*[[Media:2023 11-21 QIBA CT SLN BC-FINAL.pdf| November 21, 2023]]
*[[Media:04 05 2018 QIBA CT Small Lung Nodule BC-FINAL.pdf|April 5, 2018]]
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*[[Media:2023 10-24 QIBA CT SLN BC-FINAL-JLM.pdf| October 24, 2023]]
*[[Media:03 08 2018 QIBA CT Small Lung Nodule BC-FINAL-JM.pdf|March 8, 2018]]
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*[[Media:2023 09-19 QIBA CT SLN BC-FINAL-JLM.pdf| September 19, 2023]]
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*[[Media:2023 08-15 QIBA CT SLN BC-FINAL-JLM-JL.pdf| August 15, 2023]]
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no call in July
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*[[Media:2023 06-20 QIBA CT SLN BC-FINAL-revJLM-b.pdf| June 20, 2023]]
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*[[Media:2023 05-16 QIBA CT SLN BC-FINAL-revJLM-05.26-B.pdf| May 16, 2023]]
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*[[Media:2023 04-18 QIBA CT SLN BC-FINAL.pdf| April 18, 2023]]
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*[[Media:2021 10-07 QIBA CT SLN BC-FINAL.pdf| October 7, 2021]]
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'''''[[Small Lung Nodule BC Call Summaries Archive]]'''''
 
'''''[[Small Lung Nodule BC Call Summaries Archive]]'''''
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=====<font color=red>''Small Lung Nodule Profile''</font>=====
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=====<font color=blue>''Small Lung Nodule Profile''</font>=====
* [[Media:QIBA_CT_Vol_SmallLungNoduleAssessmentInCTScreening_2018.06.15.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.06.15''
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 +
* [[Media:QIBA CT Vol SmallLungNoduleAssessmentInCTScreening 2018.11.20.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.11.20 version''
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* [[Media:QIBA CT Vol SmallLungNoduleAssessmentInCTScreening 2018.11.18 clean.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.11.18 clean version''
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* [[Media:QIBA CT Vol SmallLungNoduleAssessmentInCTScreening 2018.11.18.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.11.18 with edits visible''
 +
* [[Media:QIBA CT Vol SmallLungNoduleAssessmentInCTScreening 2018.06.15.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.06.15''
 
* [[Media:2018-06-15 v9 QIBA SLN CommentsAndResolutions.xlsx|QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet]] ''Draft 2018.06.15''
 
* [[Media:2018-06-15 v9 QIBA SLN CommentsAndResolutions.xlsx|QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet]] ''Draft 2018.06.15''
* [[Media:QIBA_CT_Vol_SmallLungNoduleAssessmentInCTScreening_2018.02.11.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.02.11''
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* [[Media:QIBA CT Vol SmallLungNoduleAssessmentInCTScreening 2018.02.11.docx|QIBA Small Lung Nodule Profile]] ''Draft 2018.02.11''
 
* [[Media:2018-02-11 v8 QIBA SLN CommentsAndResolutions.xlsx|QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet]] ''Draft 2018.02.11''
 
* [[Media:2018-02-11 v8 QIBA SLN CommentsAndResolutions.xlsx|QIBA Small Lung Nodule Profile Comments and Resolutions Spreadsheet]] ''Draft 2018.02.11''
* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_2017.11.15+.docx|QIBA Small Lung Nodule Profile]] ''Draft 2017.11.15''
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* [[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening 2017.11.15+.docx|QIBA Small Lung Nodule Profile]] ''Draft 2017.11.15''
  
=====<font color=red>Status - ''Final Review in progress''</font>=====
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=====<font color=blue>Status - ''Final Review in progress''</font>=====
  
* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_2017.10.31.pdf|QIBA Small Lung Nodule Profile]] ''Draft 2017.10.31''
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* [[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening 2017.10.31.pdf|QIBA Small Lung Nodule Profile]] ''Draft 2017.10.31''
 
* [[Media:2017-10-07 Final QIBASmallNoduleProfileTF CommentResponse.pdf|QIBA Lung Nodule Profile Comment Response]] ''2017.10.07''
 
* [[Media:2017-10-07 Final QIBASmallNoduleProfileTF CommentResponse.pdf|QIBA Lung Nodule Profile Comment Response]] ''2017.10.07''
* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_2017.09.27.docx|QIBA Lung Nodule Profile]] ''Draft 2017.09.27''
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* [[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening 2017.09.27.docx|QIBA Lung Nodule Profile]] ''Draft 2017.09.27''
  
=====<font color=red>'''''Supporting documents:'''''</font>=====
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=====<font color=blue>'''''Supporting documents:'''''</font>=====
  
* [[Media:Ref3_SPIE2017Proceedings.pdf|Ref3_SPIE 2017 Proceedings]]
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* [[Media:Ref3 SPIE2017Proceedings.pdf|Ref3_SPIE 2017 Proceedings]]
* [[Media:Ref5_Avila_etal_IWCLCTapeQAAbstract.pdf|Ref5_Avila_et al_IWCLC Tape QA Abstract]]  
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* [[Media:Ref5 Avila etal IWCLCTapeQAAbstract.pdf|Ref5_Avila_et al_IWCLC Tape QA Abstract]]
* [[Media:Ref6_Avila_etal_WCTIHotTopicAbstract.pdf|Ref6_Avila_etal_WCTI Hot Topic Abstract]]
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* [[Media:Ref6 Avila etal WCTIHotTopicAbstract.pdf|Ref6_Avila_etal_WCTI Hot Topic Abstract]]
* [[Media:Ref7_Avila_etal_ANovel UltraLowCostCTImageQualityMeasurementDev.pdf|Ref7_Avila_et al_A Novel Ultra Low Cost CT Image Quality Measurement Dev]]
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* [[Media:Ref7 Avila etal ANovel UltraLowCostCTImageQualityMeasurementDev.pdf|Ref7_Avila_et al_A Novel Ultra Low Cost CT Image Quality Measurement Dev]]
* [[Media:Ref8_Avila_etal_AutomaticEstimationofMeasurementErroronCT Imaging.pdf|Ref8_Avila_et al_Automatic Estimation of Measurement Error on CT Imaging]]
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* [[Media:Ref8 Avila etal AutomaticEstimationofMeasurementErroronCT Imaging.pdf|Ref8_Avila_et al_Automatic Estimation of Measurement Error on CT Imaging]]
  
* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_2017.07.rev15.pdf|QIBA Lung Nodule Profile]] ''Draft 2017.08.02''
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* [[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening 2017.07.rev15.pdf|QIBA Lung Nodule Profile]] ''Draft 2017.08.02''
:* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_2017.05.15+KOD.docx|Comments on mid-May draft from Kevin]] ''2017.06.06''
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:*[[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening 2017.05.15+KOD.docx|Comments on mid-May draft from Kevin]] ''2017.06.06''
  
 
'''Status - Public Comment complete'''
 
'''Status - Public Comment complete'''
* [[Media:QIBA_CT_Vol_LungNoduleAssessmentInCTScreening_v5-2-16b.docx|QIBA Profile: CT Lung Nodule Assessment in Screening]] ''Public Comment 2016.06.01 (ended Sept 2016)''
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* [[Media:QIBA CT Vol LungNoduleAssessmentInCTScreening v5-2-16b.docx|QIBA Profile: CT Lung Nodule Assessment in Screening]] ''Public Comment 2016.06.01 (ended Sept 2016)''
:* [[Media:QIBA Small Nodule Profile References - Accuracy.xlsx|Spreadsheet: Small Nodule Profile References_Accuracy]]  
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:*[[Media:QIBA Small Nodule Profile References - Accuracy.xlsx|Spreadsheet: Small Nodule Profile References_Accuracy]]
 
:* [[Media:QIBA Small Nodule Profile References - Precision.xlsx|Spreadsheet: Small Nodule Profile References_Precision]]
 
:* [[Media:QIBA Small Nodule Profile References - Precision.xlsx|Spreadsheet: Small Nodule Profile References_Precision]]
  
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==Reference Materials==
 
==Reference Materials==
 +
 +
*[[Media:2021-10-07 All CTLX1 StudyResults.pdf| All CTLX1 Comparison Study Results, October 7, 2021]]
 +
*[[Media:03.08.2021 Stats.pdf| Statistical Considerations for Small Lung Nodule Profile Conformance, March 8, 2021]]
 
*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. [https://www.spiedigitallibrary.org/journals/Journal-of-Medical-Imaging/volume-3/issue-03/035505/Tumor-volume-measurement-error-using-computed-tomography-imaging-in-a/10.1117/1.JMI.3.3.035505.full Journal of Medical Imaging]
 
*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. [https://www.spiedigitallibrary.org/journals/Journal-of-Medical-Imaging/volume-3/issue-03/035505/Tumor-volume-measurement-error-using-computed-tomography-imaging-in-a/10.1117/1.JMI.3.3.035505.full Journal of Medical Imaging]
 
  
 
==Conformance Materials==
 
==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.
+
The QIBA CT Small Lung Nodule Profile refers to several online resources that are needed to achieve conformance.
  
 
====<font size="3"><u>Clinical Site Conformance</u></font>====
 
====<font size="3"><u>Clinical Site Conformance</u></font>====
 
<blockquote>
 
<blockquote>
=====<font color=darkblue>Verified Vendor Systems</font>=====
 
:* QIBA Verified Conformant CT Scanners: All FDA approved CT scanners are provisionally conformant and may be used at this time.
 
:* QIBA Verified Conformant Nodule Analysis Software: All FDA approved Nodule Analysis Software are provisionally conformant and may be used at this time.
 
 
=====<font color=darkblue>Phantom Data Upload Site</font>=====
 
:* [http://services.accumetra.com/CTLX1report.php QIBA Data Upload Site For Clinical Sites]
 
 
=====<font color=darkblue>Small Lung Nodule Online Calculator</font>=====
 
:* [http://services.accumetra.com/NoduleCalculator.html QIBA Small Lung Nodule Online Calculator]
 
</blockquote>
 
  
 
====<font size="3"><u>CT Scanner Vendor Conformance</u></font>====
 
====<font size="3"><u>CT Scanner Vendor Conformance</u></font>====
 
<blockquote>
 
<blockquote>
=====<font color=darkblue>Phantom Data Upload Site</font>=====
 
:* Link to QIBA Data Upload Site For CT Scanner Vendors
 
</blockquote>
 
  
 
====<font size="3"><u>Software Analysis Vendor Conformance</u></font>====
 
====<font size="3"><u>Software Analysis Vendor Conformance</u></font>====
 
<blockquote>
 
<blockquote>
=====<font color=darkblue>Phantom Nodule Dataset</font>=====
 
:* [http://qidw.rsna.org/#collection/5a0b25f91cac0a4ec8000ddf/folder/5a0c66e71cac0a4ec8000df0 Phantom Nodule Dataset V1]
 
:* Link to QIBACTSLN-PhantomNoduleDatasetLocationsV1.xls
 
:* Link to QIBACTSLN-PhantomNoduleDatasetMeasureReportingFileV1.xls
 
 
=====<font color=darkblue>Clinical Nodule Dataset</font>=====
 
:* [http://qidw.rsna.org/#collection/5a0b25f91cac0a4ec8000ddf/folder/5a0c67291cac0a4ec8000df1 Clinical Nodule Dataset V1]
 
:* Link to QIBACTSLN-ClinicalNoduleDatasetLocationsV1.xls
 
:* Link to QIBACTSLN-ClinicalNoduleDatasetMeasureReportingFileV1.xls
 
 
=====<font color=darkblue>Reporting Data Upload Site</font>=====
 
:* Link to QIBA Data Upload Site For Software Analysis Vendors
 
</blockquote>
 

Latest revision as of 18:41, 21 December 2023

Co-chairs: Artit Jirapatnakul, PhD; James L. Mulshine, MD; Kyle J. Myers, PhD


Meetings

Recent Call Summaries:

no call in July


Small Lung Nodule BC Call Summaries Archive

Profile Development

Small Lung Nodule Assessment in CT Screening Profile

Small Lung Nodule Profile
Status - Final Review in progress
Supporting documents:

Status - Public Comment complete

Past

Reference Materials

Conformance Materials

The QIBA CT Small Lung Nodule Profile refers to several online resources that are needed to achieve conformance.

Clinical Site Conformance

CT Scanner Vendor Conformance

Software Analysis Vendor Conformance