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

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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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Journal

Journal ID (iso-abbrev): Neuro-oncology

Title: Neuro-oncology

Publisher: Oxford University Press (OUP)

ISSN (Electronic): 1523-5866

ISSN (Print): 1522-8517

Publication date (Electronic): Sep 2015

Volume: 17

Issue: 9

Affiliations

[1 ] UCLA Neuro-Oncology Program and UCLA Brain Tumor Imaging Laboratory (BTIL), David Geffen School of Medicine, University of California - Los Angeles, Los Angeles, California (B.M.E., T.F.C.); Department of Radiological Sciences, David Geffen School of Medicine, University of California - Los Angeles, Los Angeles, California (B.M.E., W.B.P.); Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany (M.B.); Department of Diagnostic Imaging, Warrne Alpert Medical School, Brown University, Providence, Rhode Island (J.B.); Department of Neuroradiology, Duke University School of Medicine, Durham, North Carolina (D.B.); Department of Radiology, Mayo Clinic, Rochester, Minnesota (B.J.E.); Department of Radiology, Erasmus MC University, Rotterdam, Netherlands (M.S.); Department of Radiology and Biomedical Imaging, University of California - San Francisco, San Francisco, California (S.J.N., S.C.); Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (E.G.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts (B.A., P.Y.W.); Medical and Scientific Affairs, ICON Medical Imaging, Warrington, Pennsylvania (G.G., D.Y.); Department of Neurooncology, National Center of Tumor Disease, University Clinic Heidelberg, Heidelberg, Germany (W.W.); Department of Neurological Surgery, Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, Ohio (M.V.); Department of Neurology, University Hospital Zurich, Zurich, Switzerland (M.W.); Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota (E.G.); Martinos Center for Biomedical Imaging, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (J.K.-C.); Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), Bethesda, Maryland (L.S., P.J.); Department of Radiation Oncology, University of Toronto and Princess Margaret

Article

Publisher Item ID: nov095

DOI: 10.1093/neuonc/nov095

PMC ID: 4588759

PubMed ID: 26250565

SO-VID: 693b1ed9-d141-4537-91b9-239a22140086

History

Keywords: Brain Tumor Imaging Protocol,MRI,clinical trials,glioblastoma

Data availability:

Keywords: Brain Tumor Imaging Protocol, MRI, clinical trials, glioblastoma

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