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

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Ellingson, BM; Bendszus, M; Boxerman, J; Barboriak, D; Erickson, BJ; Smits, M; Nelson, SJ; Gerstner, E; Alexander, B; Goldmacher, G; Wick, W; Vogelbaum, M; Weller, M; Galanis, E; Kalpathy-Cramer, J; Shankar, L; Jacobs, P; Pope, WB; Yang, D; Chung, C; Knopp, MV; Cha, S; van den Bent, MJ; Chang, S; Yung, WKA; Cloughesy, TF; Wen, PY; Gilbert, MR; Jumpstarting Brain Tumor Drug Development Coalition Imaging Standardization Steering Committee,

Published Date

  • September 2015

Published In

Volume / Issue

  • 17 / 9

Start / End Page

  • 1188 - 1198

PubMed ID

  • 26250565

Pubmed Central ID

  • 26250565

Electronic International Standard Serial Number (EISSN)

  • 1523-5866

International Standard Serial Number (ISSN)

  • 1522-8517

Digital Object Identifier (DOI)

  • 10.1093/neuonc/nov095

Language

  • eng