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Purpose: To determine the patient safety profile of both oral 5-ALA as well as use of the fluorescence operative microscope including the incidence of surgically-related neurological deficits in a multicenter study. To determine whether Gliolan-induced PPIX fluorescence correlates with malignant tumor histopathology (in at least 3 serial biopsies in the fluorescent region of the tumor resection). Secondary Objectives To determine the extent of resection (EOR) on postoperative MRI by subtracting the postoperative volume of residual enhancing tumor from the preoperative initial volume of enhancing tumor. To correlate the quantity or appearance of PPIX-containing extracellular microvesicles in blood with the initial tumor volume prior to resection. To correlate PPIX and other microvesicles as a correlate of tumor MRI recurrence. These microvesicles will be evaluated at serial time points prior to and after surgery until MRI radiographic tumor progression by the RANO response criteria. Microvesicle evaluations will include PPIX, EGFRvIII, IDH1/2 and their mutations and others in tissue at time of surgery and in blood derived microparticles of tumor origin.
Purpose: The overall goal of this project is to develop an integrated system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions. This protocol will allow inclusion in the overall high risk database of the datasets obtained on the same subject from other risk assessment and/or prevention protocols. As such, this project provides a central clearinghouse for all data from a variety of protocols for which subjects have individually provided consent for the collection/assessment of specific data items. This protocol also facilitates the acquisition of biologic specimens for purposes of screening for determination of eligibility prior to signing a study-specific consent and enrolling in a specific risk assessment or intervention protocol.