Core A core Director: Bading, James Principal investigator: Raubitschek, AndrewDESCRIPTION: The overall objective of Core A is to provide state-of-the-art imaging, radiation dosimetry andpharmacokinetic modeling support for clinical trials of novel radiolabeled monoclonal antibodies (MAbs) andother immunotherapeutic agents. The primary responsibility of the Core is to help the principal investigatorsof our research projects optimize the use of imaging in their clinical study protocols. To that end, the Corewill (a) identify and implement current best practices for quantitative imaging, dosimetry of internallyadministered radioisotopes, and the use of imaging to assess and predict tumor response to therapy; and (b)perform research/development as needed to optimize the use of imaging in the clinical study protocols. TheCore A team will also provide quality assurance for instrument calibration and clinical scan acquisition. Core A is led by two highly experienced imaging physicist/radiation dosimetrist/kinetic modelers and alsoncludes a radiologist expert in clinical applications of functional imaging, an image analyst/programmer, adata base administrator/developer and an imaging research technician. A full complement of modern clinicalmaging equipment is available, including SPECT-CT and PET-CT (by the initiation of the grant). Anotherkey equipment resource is a well-integrated image processing, display and analysis system dedicated to linical research studies. In the area of pharmacokinetics and radiation dosimetry, the Core will (a) continue to perform quantitativeimage analysis and dosimetric calculations for clinical radioimmunotherapy (BIT) trials; (b) supplementplanar imaging with SPECT-CT to improve accuracy of radioactivity measurements in tumors and normalorgans; (c) implement a 3D, voxel-based method for estimating radiation absorbed dose; (d) evaluate theimpact of SPECT-CT and voxel-based dosimetry on the correlation between estimated tumor absorbed doseand response; (e) evaluate the use of kinetic modeling to differentiate among the factors affecting tumoruptake of BIT MAbs; and (f) evaluate the effect of the anti-angiogenesis agent Avastin on tumor uptake ofRIT MAbs. The Core will also undertake a major effort in the area of assessment of treatment response by(a) establishing an image response assessment team (IRAT); (b) implementing a quality assurance programfor measurements of tumor response to treatment; and (c) evaluating the use of a functional/metabolicmeasure of tumor response (PET/[18F]FDG) in our clinical therapy trials. Core A directly supports Project 1 and Project 3, which together contain all of the clinical trials proposedfor the next five years. Core A provides imaging physics, pharmacokinetic modeling and radiation dosimetrysupport to Core D (Animal Core); Core A also has primary responsibility for translating imaging advancesdeveloped in animals into clinical use. Core A indirectly supports Project 2 by developing modelingmethodology that will contribute to clinical trial design for pretargeted RIT. Core A receives support fromCore E (Biostatistics) in the areas of experimental design and data management.
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