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Evaluating Multisite rCBV Consistency from DSC-MRI Imaging Protocols and Postprocessing Software Across the NCI

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Standardizing imaging protocols improves consistency for relative cerebral blood volume (rCBV) measurements in clinical trials. However, site-specific software for rCBV analysis introduces significant variability, hindering its use as a reliable biomarker.

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Area of Science:

  • Medical Imaging
  • Biomarker Development
  • Clinical Trials

Background:

  • Relative cerebral blood volume (rCBV) is a potential biomarker for clinical trials but suffers from inconsistent measurement across sites.
  • Variations in imaging acquisition and postprocessing methods (PMs) contribute to poor biomarker consistency and interpretation.
  • Standardization efforts are crucial for reliable rCBV assessment in multi-center studies.

Purpose of the Study:

  • To evaluate the consistency of rCBV measurements across multiple clinical trial sites.
  • To identify the impact of different imaging protocols (IPs) and postprocessing methods (PMs) on rCBV consistency.
  • To provide recommendations for improving rCBV reliability as a clinical trial biomarker.

Main Methods:

  • Utilized a dynamic susceptibility contrast magnetic resonance imaging digital reference object.
  • Assessed rCBV consistency across 12 Quantitative Imaging Network (QIN) sites.
  • Analyzed variations attributed to site-specific IPs (n=17), PMs (n=19), and combined differences (n=25).

Main Results:

  • High agreement in rCBV measurements was achieved when a single center processed data, despite minor IP variations.
  • Significant inter-site disagreement was observed when sites used their own software for rCBV analysis.
  • Variability in PMs can confound therapeutic effectiveness comparisons and response threshold establishment.

Conclusions:

  • Standardizing imaging protocols is beneficial but insufficient for consistent rCBV measurements.
  • Site-specific postprocessing software is a major source of variability, challenging rCBV's role as a biomarker.
  • Establishing qualifying and validating criteria for imaging hardware and analysis software is recommended to ensure rCBV's clinical utility.