Radiographic read paradigms and the roles of the central imaging laboratory in neuro-oncology clinical trials

Benjamin M. Ellingson, Matthew S. Brown, Jerrold L. Boxerman, Elizabeth R. Gerstner, Timothy J. Kaufmann, Patricia E. Cole, Jeffrey A. Bacha, David Leung, Amy Barone, Howard Colman, Martin J. van den Bent, Patrick Y. Wen, W. K. Alfred Yung, Timothy F. Cloughesy, Jonathan G. Goldin

Research output: Contribution to journalArticlepeer-review

Abstract

Determination of therapeutic benefit in intracranial tumors is intimately dependent on serial assessment of radiographic images. The Response Assessment in Neuro-Oncology (RANO) criteria were established in 2010 to provide an updated framework to better characterize tumor response to contemporary treatments. Since this initial update a number of RANO criteria have provided some basic principles for the interpretation of changes on MR images; however, the details of how to operationalize RANO and other criteria for use in clinical trials are ambiguous and not standardized. In this review article designed for the neuro-oncologist or treating clinician, we outline essential steps for performing radiographic assessments by highlighting primary features of the Imaging Charter (referred to as the Charter for the remainder of this article), a document that describes the clinical trial imaging methodology and methods to ensure operationalization of the Charter into the workings of a clinical trial. Lastly, we provide recommendations for specific changes to optimize this methodology for neuro-oncology, including image registration, requirement of growing tumor for eligibility in trials of recurrent tumor, standardized image acquisition guidelines, and hybrid reader paradigms that allow for both unbiased measurements and more comprehensive interpretation.

Original languageEnglish (US)
Pages (from-to)189-198
Number of pages10
JournalNeuro-oncology
Volume23
Issue number2
DOIs
StatePublished - Feb 25 2021

Keywords

  • clinical trials
  • Imaging Charter
  • imaging endpoints
  • neuro-oncology
  • RANO

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology
  • Cancer Research

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