title: Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials neuroimaging endpoint workshop (January 30, 2014, Bethesda MD).
abstract: On January 30, 2014, a workshop was held on neuroimaging endpoints in high-grade glioma. This workshop was sponsored by the Jumpstarting Brain Tumor Drug Development Coalition, consisting of the National Brain Tumor Society, the Society for Neuro-Oncology, Accelerate Brain Cancer Cure, and the Musella Foundation for Research and Information, and conducted in collaboration with the Food and Drug Administration. The workshop included neuro-oncologists, neuroradiologists, radiation oncologists, neurosurgeons, biostatisticians, patient advocates, and representatives from industry, clinical research organizations, and the National Cancer Institute. This report summarizes the presentations and discussions of that workshop and the proposals that emerged to improve the Response Assessment in Neuro-Oncology (RANO) criteria and standardize neuroimaging parameters.
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Cloughesy
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Ellingson
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: David A
authors.initials: DA
authors.lastname: Reardon
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Howard A
authors.initials: HA
authors.lastname: Fine
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Lauren
authors.initials: L
authors.lastname: Abrey
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Karla
authors.initials: K
authors.lastname: Ballman
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Martin
authors.initials: M
authors.lastname: Bendszuz
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Jan
authors.initials: J
authors.lastname: Buckner
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Michael D
authors.initials: MD
authors.lastname: Prados
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Whitney B
authors.initials: WB
authors.lastname: Pope
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Alma
authors.initials: A
authors.lastname: Gregory Sorensen
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Martin
authors.initials: M
authors.lastname: van den Bent
authors.affiliation: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W., D.A.R.); University of California, Los Angeles School of Medicine, Los Angeles, California (T.F.C., B.M.E., W.B.P.); New York University Langone Medical Center, New York, New York (H.A.F.); Hoffmann-La Roche, Basel, Switzerland (L.A.); Department of Biostatistics, Mayo Clinic Rochester, Rochester, Minnesota (K.B.); Department of Neuro-radiology, University of Heidelberg, Heidelberg, Germany (M.B.); Department of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota (J.B.); Brain Tumor Center, University of California, San Francisco, California (S.M.C., M.D.P.); Siemens Healthcare North America, Malvern, Pennsylvania (A.G.S.); Department of Neuro-Oncology, Erasmus M.C.-Daniel den Hoed Cancer Center, Rotterdam, Netherlands (M.v.d.B.); Department of Neuro-Oncology, M.D. Anderson Cancer Center, Houston, Texas (W-K.A.Y.).
authors.forename: Wai-Kwan Alfred
authors.initials: WK
authors.lastname: Yung
mesh_terms: D001932:Brain Neoplasms / Q000175:diagnosis* / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D023381:Endpoint Determination; D005910:Glioma / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods / Q000639:trends; D059906:Neuroimaging / Q000379:methods* / Q000639:trends; D049268:Positron-Emission Tomography / Q000379:methods / Q000639:trends; D066066:Response Evaluation Criteria in Solid Tumors
keywords: RANO; brain tumor; endpoints; neuroimaging; workshop