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

Benjamin M. Ellingson, Martin Bendszus, Jerrold Boxerman, Daniel Barboriak, Bradley J. Erickson, Marion Smits, Sarah J. Nelson, Elizabeth Gerstner, Brian Alexander, Gregory Goldmacher, Wolfgang Wick, Michael Vogelbaum, Michael Weller, Evanthia Galanis, Jayashree Kalpathy-Cramer, Lalitha Shankar, Paula Jacobs, Whitney B. Pope, Dewen Yang, Caroline Chung & 15 others Michael V. Knopp, Soonme Cha, Martin J. Van Den Bent, Susan Chang, W. K. Al Yung, Timothy F. Cloughesy, Patrick Y. Wen, Mark R. Gilbert, Andrew Whitney, David Sandak, Al Musella, Chas Haynes, Max Wallace, David F. Arons, Ann Kingston

Research output: Contribution to journalArticle

138 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1188-1198
Number of pages11
JournalNeuro-Oncology
Volume17
Issue number9
DOIs
StatePublished - Sep 1 2015
Externally publishedYes

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Neuroimaging
Brain Neoplasms
Clinical Trials
National Cancer Institute (U.S.)
United States Food and Drug Administration
Glioblastoma
Multicenter Studies
Education
Injections
Pharmaceutical Preparations

Keywords

  • Brain Tumor Imaging Protocol
  • clinical trials
  • glioblastoma
  • MRI

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Clinical Neurology

Cite this

Ellingson, B. M., Bendszus, M., Boxerman, J., Barboriak, D., Erickson, B. J., Smits, M., ... Kingston, A. (2015). Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials. Neuro-Oncology, 17(9), 1188-1198. https://doi.org/10.1093/neuonc/nov095

Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials. / Ellingson, Benjamin M.; Bendszus, Martin; Boxerman, Jerrold; Barboriak, Daniel; Erickson, Bradley J.; Smits, Marion; Nelson, Sarah J.; Gerstner, Elizabeth; Alexander, Brian; Goldmacher, Gregory; Wick, Wolfgang; Vogelbaum, Michael; Weller, Michael; Galanis, Evanthia; Kalpathy-Cramer, Jayashree; Shankar, Lalitha; Jacobs, Paula; Pope, Whitney B.; Yang, Dewen; Chung, Caroline; Knopp, Michael V.; Cha, Soonme; Van Den Bent, Martin J.; Chang, Susan; Al Yung, W. K.; Cloughesy, Timothy F.; Wen, Patrick Y.; Gilbert, Mark R.; Whitney, Andrew; Sandak, David; Musella, Al; Haynes, Chas; Wallace, Max; Arons, David F.; Kingston, Ann.

In: Neuro-Oncology, Vol. 17, No. 9, 01.09.2015, p. 1188-1198.

Research output: Contribution to journalArticle

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, Al Yung, WK, Cloughesy, TF, Wen, PY, Gilbert, MR, Whitney, A, Sandak, D, Musella, A, Haynes, C, Wallace, M, Arons, DF & Kingston, A 2015, 'Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials', Neuro-Oncology, vol. 17, no. 9, pp. 1188-1198. https://doi.org/10.1093/neuonc/nov095
Ellingson BM, Bendszus M, Boxerman J, Barboriak D, Erickson BJ, Smits M et al. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials. Neuro-Oncology. 2015 Sep 1;17(9):1188-1198. https://doi.org/10.1093/neuonc/nov095
Ellingson, Benjamin M. ; Bendszus, Martin ; Boxerman, Jerrold ; Barboriak, Daniel ; Erickson, Bradley J. ; Smits, Marion ; Nelson, Sarah J. ; Gerstner, Elizabeth ; Alexander, Brian ; Goldmacher, Gregory ; Wick, Wolfgang ; Vogelbaum, Michael ; Weller, Michael ; Galanis, Evanthia ; Kalpathy-Cramer, Jayashree ; Shankar, Lalitha ; Jacobs, Paula ; Pope, Whitney B. ; Yang, Dewen ; Chung, Caroline ; Knopp, Michael V. ; Cha, Soonme ; Van Den Bent, Martin J. ; Chang, Susan ; Al Yung, W. K. ; Cloughesy, Timothy F. ; Wen, Patrick Y. ; Gilbert, Mark R. ; Whitney, Andrew ; Sandak, David ; Musella, Al ; Haynes, Chas ; Wallace, Max ; Arons, David F. ; Kingston, Ann. / Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials. In: Neuro-Oncology. 2015 ; Vol. 17, No. 9. pp. 1188-1198.
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