权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Clinical Trials and Imaging Core

临床试验和影像核心

基本信息

批准号：
10006182
负责人：
Annick Desjardins
金额：
$ 21.62万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10006182
关键词：
Adopted Adult Antibody Therapy Automation Bioinformatics Biometry Biopsy Brain Neoplasms Case Report Form Clinical Clinical Data Clinical Management Clinical Research Clinical Trials Clinical trial protocol document Clinical/Radiologic Conduct Clinical Trials Conflict of Interest Consent Consent Forms Correlative Study Cytomegalovirus Data Data Collection Databases Development Diagnostic radiologic examination Diphtheria Toxoid Disease Enrollment Ensure Evaluation Federal Government Future Glioblastoma Goals Grant Health system Human Resources Image Image Analysis Immunologic Monitoring Immunotherapeutic agent Immunotherapy Infusion procedures Injections Institutes Instruction Interdisciplinary Communication International Investigational Therapies Lead Leadership Lomustine Magnetic Resonance Magnetic Resonance Imaging Malignant Neoplasms Manuscripts Measurement Monoclonal Antibodies Nurse Practitioners Nursing Research Oncolytic poliovirus Oral Patient Care Patient Recruitments Patient-Focused Outcomes Patients Performance Preparation Procedures Process Protocols documentation Publications Quality of life RNA Radiology Specialty Recording of previous events Research Research Design Safety Science Side Specialist Standardization Techniques Tetanus Therapeutic Clinical Trial Tissues Training Translational Research Universities Vaccines Work automated image analysis biobank brain tumor imaging clinical imaging cost data management follow up assessment imaging modality immunotherapy trials improved innovation interdisciplinary collaboration meetings monocyte multidisciplinary neuro-oncology novel novel therapeutics operation patient population preconditioning programs protocol development quality assurance recruit response screening treatment trial trial comparing tumor

项目摘要

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.

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。