Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

Benjamin M. Ellingson(University of California, Los Angeles), Martin Bendszus(University of California, Los Angeles), Jerrold L. Boxerman(University of California, Los Angeles), Daniel P. Barboriak(University of California, Los Angeles), Bradley J. Erickson(University of California, Los Angeles), Marion Smits(University of California, Los Angeles), Sarah J. Nelson(University of California, Los Angeles), Elizabeth R. Gerstner(University of California, Los Angeles), Brian M. Alexander(University of California, Los Angeles), Gregory Goldmacher(University of California, Los Angeles), Wolfgang Wick(University of California, Los Angeles), Michael A. Vogelbaum(University of California, Los Angeles), Michael Weller(University of California, Los Angeles), Evanthia Galanis(University of California, Los Angeles), Jayashree Kalpathy–Cramer(University of California, Los Angeles), Lalitha Shankar(University of California, Los Angeles), Paula Jacobs(University of California, Los Angeles), Whitney B. Pope(University of California, Los Angeles), Dewen Yang(University of California, Los Angeles), Caroline Chung(University of California, Los Angeles), Michael V. Knopp(University of California, Los Angeles), Soonme Cha(University of California, Los Angeles), Martin J. van den Bent(University of California, Los Angeles), Susan Chang(University of California, Los Angeles), Wai Kuen Yung(University of California, Los Angeles), Timothy F. Cloughesy(University of California, Los Angeles), Patrick Y. Wen(University of California, Los Angeles), Mark R. Gilbert(University of California, Los Angeles)
Neuro-Oncology
August 6, 2015
Cited by 664Open Access
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Abstract

A recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss imaging endpoints for clinical trials in glioblastoma. This workshop developed a set of priorities and action items including the creation of a standardized MRI protocol for multicenter studies. The current document outlines consensus recommendations for a standardized Brain Tumor Imaging Protocol (BTIP), along with the scientific and practical justifications for these recommendations, resulting from a series of discussions between various experts involved in aspects of neuro-oncology neuroimaging for clinical trials. The minimum recommended sequences include: (i) parameter-matched precontrast and postcontrast inversion recovery-prepared, isotropic 3D T1-weighted gradient-recalled echo; (ii) axial 2D T2-weighted turbo spin-echo acquired after contrast injection and before postcontrast 3D T1-weighted images to control timing of images after contrast administration; (iii) precontrast, axial 2D T2-weighted fluid-attenuated inversion recovery; and (iv) precontrast, axial 2D, 3-directional diffusion-weighted images. Recommended ranges of sequence parameters are provided for both 1.5 T and 3 T MR systems.


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