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Dynamic contrast-enhanced MRI in clinical trials of antivascular therapies

James P B O'Connor1, Alan Jackson, Geoff J M Parker

  • 1Imaging, Genomics and Proteomics Research Group, School of Cancer and Enabling Sciences, University of Manchester, Oxford Road, Manchester M13 9PT, UK. james.o'connor@ manchester.ac.uk

Nature Reviews. Clinical Oncology
|February 15, 2012
PubMed

Insights

Dynamic contrast-enhanced MRI (DCE-MRI) shows promise as a biomarker in early cancer drug trials. Multiparametric analysis may offer greater insight than single parameters like Ktrans for guiding drug development.

Area of Science:

  • Oncology
  • Radiology
  • Pharmacodynamics

Background:

  • Over 100 early-phase trials use T1-weighted dynamic contrast-enhanced MRI (DCE-MRI) for targeted antivascular therapies.
  • The utility of DCE-MRI in guiding drug development decisions remains debated.
  • Key questions persist regarding DCE-MRI's role in early-phase clinical trial design.

Purpose of the Study:

  • To review studies incorporating DCE-MRI parameters as pharmacodynamic biomarkers in single-agent antivascular therapy trials.
  • To assess the reproducibility and reliability of DCE-MRI parameters (e.g., Ktrans) for drug efficacy and proof of concept.
  • To evaluate DCE-MRI's contribution to dose selection and scheduling for Phase II trials.

Main Methods:

  • Review of published studies on single-agent antivascular therapies using DCE-MRI.
  • Analysis of DCE-MRI parameters as pharmacodynamic biomarkers.
  • Discussion of multiparametric analysis versus single-parameter analysis (e.g., Ktrans).

Main Results:

  • DCE-MRI parameters are incorporated as pharmacodynamic biomarkers in early-phase trials.
  • Reproducibility and reliability of parameters like Ktrans for efficacy and proof of concept are under scrutiny.
  • Emerging evidence suggests multiparametric DCE-MRI analysis provides deeper insights into drug mechanisms.

Conclusions:

  • DCE-MRI shows potential as a biomarker in oncology drug development.
  • Multiparametric analysis of DCE-MRI data may be superior to single-parameter analysis for understanding drug action.
  • Hurdles in biomarker development, validation, and qualification impede wider clinical trial application of DCE-MRI.

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