PROJECT SUMIVIARY (See instructions): Shared Resource Core A. Imaging. Daniel Barboriak, M.D., Core Director The role of the Imaging Core is to evaluate therapeutic response for novel therapies in neuro-oncology and to evaluate treatment delivery. The Imaging Core has five Specific Aims/Goals. 1. To perform and implement response assessment based on a modification of RECIST 1.1 in patients with neoplastic meningitis being treated with [211]-At-labeled trastuzumab and panitumumab. The modification of RECIST 1.1 of Project 1 will allow the treatment response as evaluated by cerebrospinal fluid (CSF) cytology to be integrated with the imaging-based response. Successful implementation of this image response assessment will be ensured using a quality control regimen which includes training sessions, oversight and review by subspecialty board-certified neuroradiologists with at least 2 years of subspecialty experience, and auditing of cases by the Core Director. 2. To perform and implement RANO (response assessment in neuro-oncology) criteria for evaluation of response in patients undergoing immunotherapy for newly diagnosed glioblastoma multiforme (GSM, Project 2) and immunotoxin treatment for recurrent GBM (Project 3). The implementation considerations for this new image response assessment are identical to those above. 3. To assess dose distribution of EGFR and EGFRvlll-dual-specific Immunotoxin (Project 3), using combined gadolinium and [124]I -albumin infusion to evaluate convection-enhanced delivery (CED). As part of this project, imaging results will be used to improve the simulation of CED dose distribution. 4. To evaluate the distribution of [124] l-labeled trastuzumab by PET imaging of both animal and human subjects. These experiments will evaluate the potential utility of [124] l-labeled trastuzumab as a PET Imaging probe for monitoring response to therapy and possibly define dose-response relationships. 5. To oversee and provide technical support for the administration of radiopharmaceuticals. This includes fluoroscopically-guided access of the Rickham or Ommaya reservoirs (Project 1) and overseeing the radioactive component of the intratumoral infusions (Project 3).

Public Health Relevance

Core activities will test the feasibility and face validity of therapeutic evaluation using the RECIST 1.1 and RANO criteria, which have yet to be broadly implemented in clinical neuro-imaging trials and may or may not be valid for evaluation of novel radio-antibody, immunotoxin or immunotherapy treatments. The effectiveness of convection-enhanced dose delivery will be evaluated using gamma camera and PET scanning

National Institute of Health (NIH)
National Cancer Institute (NCI)
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Duke University
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