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; 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; Jumpstarting Brain Tumor Drug Development Coalition Imaging Standardization Steering Committee

doi:10.1093/neuonc/nov095

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

Neuro Oncol. 2015 Sep;17(9):1188-98. doi: 10.1093/neuonc/nov095. Epub 2015 Aug 5.

Authors

Benjamin M Ellingson¹, Martin Bendszus¹, Jerrold Boxerman¹, Daniel Barboriak¹, Bradley J Erickson¹, Marion Smits¹, Sarah J Nelson¹, Elizabeth Gerstner¹, Brian Alexander¹, Gregory Goldmacher¹, Wolfgang Wick¹, Michael Vogelbaum¹, Michael Weller¹, Evanthia Galanis¹, Jayashree Kalpathy-Cramer¹, Lalitha Shankar¹, Paula Jacobs¹, Whitney B Pope¹, Dewen Yang¹, Caroline Chung¹, Michael V Knopp¹, Soonme Cha¹, Martin J van den Bent¹, Susan Chang¹, W K Al Yung¹, Timothy F Cloughesy¹, Patrick Y Wen¹, Mark R Gilbert¹; Jumpstarting Brain Tumor Drug Development Coalition Imaging Standardization Steering Committee

Collaborators

Jumpstarting Brain Tumor Drug Development Coalition Imaging Standardization Steering Committee:
Andrew Whitney, David Sandak, Al Musella, Chas Haynes, Max Wallace, David F Arons, Ann Kingston

Affiliation

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

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.

Keywords: Brain Tumor Imaging Protocol; MRI; clinical trials; glioblastoma.

Publication types

Consensus Development Conference, NIH
Research Support, Non-U.S. Gov't
Review

MeSH terms

Brain Neoplasms / pathology*
Clinical Protocols / standards
Clinical Trials as Topic / standards
Contrast Media / administration & dosage
Humans
Image Enhancement
Magnetic Resonance Imaging / methods*
Magnetic Resonance Imaging / standards*
Neuroimaging / methods*
Neuroimaging / standards*

Substances

Contrast Media

Grants and funding

U01 CA154601/CA/NCI NIH HHS/United States