Clinical Trials and Imaging Core

项目摘要-核心2 临床试验和成像核心(核心2)将提供支持所需的领导和专业知识 三个方案的临床研究。该核心还将重点评估采用 脑肿瘤成像协议(BTIP)作为临床试验的标准化成像采集协议。 核心领导力包括神经肿瘤学、神经放射学和临床试验操作方面的专业知识。《核心》 将由Preston Robert Tisch脑肿瘤临床研究主任Annick Desjardins博士领导 中心在杜克大学。她将与Barboriak博士一起参加，他是一名神经放射科医生，专注于 脑肿瘤治疗的评价。Desjardins博士将与所有三个拟议项目的负责人进行互动 成功地进行临床试验。临床试验和成像核心将支持实际 进行临床试验，包括提供临床医生、研究经理、研究护士、研究 护士、临床试验协调员、监管人员和数据协调员。Desjardins博士 将确保来自以下工作的临床试验的开发、成功进行和发布 三个项目，确保编写进行研究所需的所有文件 (例如：协议、同意书、IND提交的临床方面、实施标准 文件)、监管管理、数据收集和数据发布。Barboriak医生将会是 负责参加由以下机构支持的临床试验的患者的所有放射学评估 赠款，包括对半自动方法(TREXT)的评估，以确定它是否提供 结果增强了与标准临床读数相当的测量结果，并且性能不低于 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.