Difference between revisions of "DSC MRI Biomarker Ctte"

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(DSC MRI Meetings)
 
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:Co-chairs: Bradley Erickson, MD, PhD; Ona Wu, PhD
 
:Co-chairs: Bradley Erickson, MD, PhD; Ona Wu, PhD
 
:RSNA Staff Support: Susan Stanfa
 
:RSNA Staff Support: Susan Stanfa
* [http://tinyurl.com/QIBA-DSC-MRI-Roster Roster]
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* [https://docs.google.com/spreadsheets/d/e/2PACX-1vSj4UaTtwxjce5uTwiOxw6bjbWwH1q82nhNMsyOsOJJy_mGEsaxky---jmU5B42nShc--icFt4T1Kok/pubhtml?gid=1048658726&single=true Roster]
  
  
 
==Project Snapshot==
 
==Project Snapshot==
Develop a quantitative imaging profile for Dynamic Susceptibility Contrast MRI.
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Develop a quantitative imaging profile for Dynamic Susceptibility Contrast MRI.
  
  
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This QIBA Profile, Dynamic-Susceptibility-Contrast Magnetic Resonance Imaging (DSC-MRI), released 2020-10-22, addresses the measurement of an imaging biomarker for relative Cerebral Blood Volume (rCBV) for the evaluation of brain tumor progression or response to therapy. We note here, that this profile does not claim to be measuring quantitative rCBV due to lack of existing supporting literature; it does provide claims for a biomarker that is proportional to rCBV, which is the tissue-normalized area under the contrast-agent concentration curve (AUC-TN). The AUC-TN therefore has merit as a potential biomarker for diseases or treatments that impact rCBV.
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This profile places requirements on Sites, Acquisition Devices, Contrast Injectors, Contrast Media, Radiologists, Physicists, Technologists, Reconstruction Software, Image Analysis Tools and Image Analysts  involved in Site Conformance, Staff Qualification, Product Validation, Pre-delivery, Periodic QA, Protocol Design, Subject Handling, Image Data Acquisition, Image Data Reconstruction, Image QA, Image Distribution, Image Analysis and Image Interpretation. The requirements are focused on achieving known (ideally negligible) bias and avoiding unnecessary variability of the of the AUC-TN measurements.
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The clinical performance is characterized by a 95% confidence interval for a true change in AUC-TN in enhancing tumor tissue and in normal tissue with respect to baseline values. These estimates are based on current literature values but may be updated based on future studies.
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This profile is intended to help clinicians basing decisions on this biomarker, imaging staff generating this biomarker, vendor staff developing related products, purchasers of such products and investigators designing trials with imaging endpoints.
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Note that this profile only states requirements to achieve the claim, '''not''' “requirements on standard of care.”  Conformance to this Profile is secondary to properly caring for the patient.
  
 
==DSC MRI Meetings==
 
==DSC MRI Meetings==
 
'''Recent Approved call summaries:'''
 
'''Recent Approved call summaries:'''
<br />Note: The last meeting of this group was held on May 8, 2019; notes are posted after they are approved by the DSC-MRI BC during the following t-con
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<br />Note: Call summaries are posted after they are approved by the DSC-MRI BC during the following t-con
  
*[[Media:2019_04-10_QIBA_DSC_Biomarker_Cmte_Call_Summary-FINAL.pdf|April 10, 2019]]
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*[[Media:2021_01-13_QIBA_DSC-MRI_BC_Call_Summary-FINAL.pdf|January 13, 2021]]
*[[Media:2019_03-13_QIBA_DSC_Biomarker_Cmte_Call_Summary-FINAL.pdf|March 13, 2019]]
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*[[Media:2020_10-14_QIBA_DSC-MRI_BC_Call_Summary-FINAL.pdf|October 14, 2020]]
*[[Media:2019_02-13_QIBA_DSC_Biomarker_Cmte_Call_Summary-FINAL.pdf|February 13, 2019]]
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*[[Media:2020_09-09_QIBA_DSC-MRI_BC_Call_Summary-FINAL.pdf|September 9, 2020]]
  
 
'''''[[DSC-MRI Call Summaries Archive]]'''''
 
'''''[[DSC-MRI Call Summaries Archive]]'''''
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* Earlier materials can be found on the [[Perfusion, Diffusion and Flow-MRI tech ctte|PDF-MRI (Perfusion, Diffusion and Flow) Biomarker Committee]] page
 
* Earlier materials can be found on the [[Perfusion, Diffusion and Flow-MRI tech ctte|PDF-MRI (Perfusion, Diffusion and Flow) Biomarker Committee]] page
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<br/>
  
 
==Profile Development==
 
==Profile Development==
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*[[Media:QIBA_DSC-MRI_Stage1_Profile.pdf |DSC Profile Stage 1 Version for Public Comment]] (comments closed on May 15, 2020)
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*[[Media:QIBA_DSC-MRI_Stage2-Consensus_Profile.pdf| DSC Profile Stage 2 Consensus Profile (released 2020-10-22)]]
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<br/>
  
 
==Historical Background - Formation of the Group==
 
==Historical Background - Formation of the Group==
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<br/>
  
 
==Reference Materials==
 
==Reference Materials==
  
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*[[Media:QIBA DSC Phantom Manual.pdf|QIBA/NIST DSC Phantom User & Software Manual]]
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*[http://qibadscdro.rsna.org/home DSC MRI Digital Reference Object]
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<br/>
  
 
==QIBA Funded Projects==
 
==QIBA Funded Projects==
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*[[Media:DSC-MRI Phantom.pdf|Project (H) Dynamic Susceptibility Contrast MRI Phantom (Massachusetts General Hospital)]]
 
*[[Media:DSC-MRI Phantom.pdf|Project (H) Dynamic Susceptibility Contrast MRI Phantom (Massachusetts General Hospital)]]
  
Original Proposal to the QIBA Steering Committee
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:Original Proposal to the QIBA Steering Committee
  
 
====Round 6====
 
====Round 6====
 
*[[Media:A Web-based Tool for Creating DSC DROs.pdf | Project (Y) A Web-based Tool for Creating DSC Digital Reference Objects (DROs) (Mayo Clinic)]]
 
*[[Media:A Web-based Tool for Creating DSC DROs.pdf | Project (Y) A Web-based Tool for Creating DSC Digital Reference Objects (DROs) (Mayo Clinic)]]

Latest revision as of 18:08, 10 February 2021

Co-chairs: Bradley Erickson, MD, PhD; Ona Wu, PhD
RSNA Staff Support: Susan Stanfa


Project Snapshot

Develop a quantitative imaging profile for Dynamic Susceptibility Contrast MRI.


This QIBA Profile, Dynamic-Susceptibility-Contrast Magnetic Resonance Imaging (DSC-MRI), released 2020-10-22, addresses the measurement of an imaging biomarker for relative Cerebral Blood Volume (rCBV) for the evaluation of brain tumor progression or response to therapy. We note here, that this profile does not claim to be measuring quantitative rCBV due to lack of existing supporting literature; it does provide claims for a biomarker that is proportional to rCBV, which is the tissue-normalized area under the contrast-agent concentration curve (AUC-TN). The AUC-TN therefore has merit as a potential biomarker for diseases or treatments that impact rCBV.

This profile places requirements on Sites, Acquisition Devices, Contrast Injectors, Contrast Media, Radiologists, Physicists, Technologists, Reconstruction Software, Image Analysis Tools and Image Analysts involved in Site Conformance, Staff Qualification, Product Validation, Pre-delivery, Periodic QA, Protocol Design, Subject Handling, Image Data Acquisition, Image Data Reconstruction, Image QA, Image Distribution, Image Analysis and Image Interpretation. The requirements are focused on achieving known (ideally negligible) bias and avoiding unnecessary variability of the of the AUC-TN measurements.

The clinical performance is characterized by a 95% confidence interval for a true change in AUC-TN in enhancing tumor tissue and in normal tissue with respect to baseline values. These estimates are based on current literature values but may be updated based on future studies.

This profile is intended to help clinicians basing decisions on this biomarker, imaging staff generating this biomarker, vendor staff developing related products, purchasers of such products and investigators designing trials with imaging endpoints.

Note that this profile only states requirements to achieve the claim, not “requirements on standard of care.” Conformance to this Profile is secondary to properly caring for the patient.

DSC MRI Meetings

Recent Approved call summaries:
Note: Call summaries are posted after they are approved by the DSC-MRI BC during the following t-con

DSC-MRI Call Summaries Archive


Profile Development


Historical Background - Formation of the Group


Reference Materials


QIBA Funded Projects

Round 5

Original Proposal to the QIBA Steering Committee

Round 6