Clinical Trials and Imaging Core

项目概要-核心2 临床试验和成像核心（核心2）将提供所需的领导和专业知识， 三个项目的临床研究。本核心报告还将重点评估采用 脑肿瘤成像协议（BTIP）作为临床试验的标准化成像采集协议。 核心领导层包括神经肿瘤学、神经放射学和临床试验运营方面的专业知识。核心 将由普雷斯顿罗伯特·蒂施脑肿瘤临床研究主任安尼克·德斯贾丁斯博士领导 杜克中心。Barboriak博士将加入她的行列，Barboriak博士是神经放射学家，在神经外科领域有着特定的研究重点。 脑肿瘤治疗的评估。Desjardins博士将与所有三个拟议项目的领导人进行互动 成功进行临床试验临床试验和成像核心将支持实际 开展临床试验，包括提供临床医生、研究经理、研究护士、研究 执业护士、临床试验协调员、监管人员和数据协调员。德斯贾丁博士 将确保来自以下工作的临床试验的开发、成功实施和出版： 三个项目，确保制定开展研究所需的所有文件 (for例如：方案、知情同意书、IND提交的临床方面、实践标准 文件）、法规管理、数据收集和数据发布。巴博里亚克博士将 负责在入组临床试验的患者中获得的所有影像学评估， 补助金，包括半自动化方法（TREXT）的评估，以确定它是否给 增强测量结果，与标准临床读数相当，且性能不差于 预测疾病状态的标准方法。

PROJECT SUMMARY – Core 2 The Clinical Trials and Imaging Core (Core 2) will provide the leadership and expertise needed to support the clinical research of the three projects. This Core will also focus on evaluating the benefits of adopting the brain tumor imaging protocol (BTIP) as a standardized imaging acquisition protocol for clinical trials. Core leadership includes expertise in neuro-oncology, neuro-radiology and clinical trial operations. The Core will be lead by Dr. Annick Desjardins, Director of Clinical Research at the Preston Robert Tisch Brain Tumor Center at Duke. She will be joined by Dr. Barboriak, neuroradiologist with a specific research focus in the evaluation of brain tumor therapies. Dr. Desjardins will interact with the leaders of all three proposed Projects to successfully conduct the clinical trials. The Clinical Trials and Imaging Core will support the actual conduct of the clinical trials, including providing clinicians, research manager, research nurses, research nurse practitioner, clinical trial coordinators, regulatory personnel and data coordinators. Dr. Desjardins will assure the development, successful conduct and publication of the clinical trials coming from the work of the three Projects, by assuring the development of all the required documents for the conduct of the study (for example: protocols, consent forms, clinical side of IND submission, standard of practice documents), regulatory management, data collection and data publication. Dr. Barboriak will be responsible for all radiographic assessments obtained in patients enrolled in the clinical trials supported by the grant, including the assessment of the semi-automated approach (TREXT) to determine if it gives results to enhance measurement that are comparable to standard clinical read and perform no worse than the standard approach for prediction of disease status.