DSC MRI Biomarker Ctte

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Co-chairs: Leland S. Hu, MD; Mark S. Shiroishi, MD; Ona Wu, PhD

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