Diagnostic Nodal Staging with Nuclear and NIR Molecular Optical Imaging

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The primary project will focus upon translation of imaging agents and devices developed at The Baylor College of Medicine (BCM) and translated in Phase I studies at The Michael E. DeBakey Veterans Administration Medical Center (MEDVAMC) as well as at Ben Taub General Hospital (BTGH). Dual labeled imaging agents for nuclear and fluorescence imaging will be produced under the BCM and LI-COR expertise in the Chemistry Core; imaged with near-infrared (NIR) fluorescence imaging and tomography devices built and algorithms written in the Instrumentation and Tomography Task Specific Projects; and approved following combinational FDA applications developed with safety and toxicity data generated in the Preclinical Testing Core. Initially we will translate two established agents which target (i) cancer cells within the lymphatic space and (ii) the reorganization of the stromal lymph node compartment as a hallmark of tumor malignancy in both breast cancer and melanoma patients. The results from Task Specific Projects that successfully validate additional candidate imaging agents will then be fed into the infrastructure of the primary project to conduct Phase 1 and Phase I/I I studies demonstrating nodal staging in Nuclear Medicine, intraoperative guidance for lymph node removal, and accurate molecular pathology. Provisions for including other consortia members are "build into" the infrastructure of the network for nodal staging of cancer. This Network for Translational Research builds upon over a decade of development of (i) NIR conjugates for cancer targeting, (ii)novel instrumentation for time-dependent measurement of fluorescence in deep tissues, and (iii) innovative algorithms which enable non-contact imaging and integration with nuclear imaging modalities.