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Clinical Trials and Imaging Core

临床试验和影像核心

基本信息

批准号：
10477343
负责人：
Annick Desjardins
金额：
$ 22.9万
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 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10477343
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 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 therapeutic intervention operation patient population preconditioning programs protocol development quality assurance radiological imaging 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.

专题总结-核心二