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启动脑肿瘤药物开发联盟与美国食品药品监督管理局(FDA)临床试验神经影像学终点研讨会报告(2014年1月30日,马里兰州贝塞斯达)

Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials neuroimaging endpoint workshop (January 30, 2014, Bethesda MD).

作者信息

Wen Patrick Y, Cloughesy Timothy F, Ellingson Benjamin M, Reardon David A, Fine Howard A, Abrey Lauren, Ballman Karla, Bendszuz Martin, Buckner Jan, Chang Susan M, Prados Michael D, Pope Whitney B, Gregory Sorensen Alma, van den Bent Martin, Yung Wai-Kwan Alfred

机构信息

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.).

出版信息

Neuro Oncol. 2014 Oct;16 Suppl 7(Suppl 7):vii36-47. doi: 10.1093/neuonc/nou226.

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.

摘要

2014年1月30日,举办了一场关于高级别胶质瘤神经影像学终点的研讨会。该研讨会由启动脑肿瘤药物开发联盟赞助,该联盟由国家脑肿瘤协会、神经肿瘤学会、加速脑癌治愈组织以及穆塞拉研究与信息基金会组成,并与美国食品药品监督管理局合作举办。研讨会参会人员包括神经肿瘤学家、神经放射学家、放射肿瘤学家、神经外科医生、生物统计学家、患者权益倡导者以及来自行业、临床研究组织和美国国立癌症研究所的代表。本报告总结了该研讨会的报告与讨论内容,以及为改进神经肿瘤反应评估(RANO)标准和规范神经影像学参数而提出的建议。

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