Clinical Trials and Imaging Core

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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.