Grant: $356,093 - National Institutes of Health - May. 19, 2009
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Award Description: The primary goal of this project is to evaluate the role of FDG PET and its ability to predict early treatment response and drug resistance in advanced epithelial ovarian cancer (AOC). A vast majority of ovarian cancer patients present with advanced stages of the disease and are managed using tumor reductive surgery, followed by multi-agent platinum-based chemotherapy. In nearly one quarter of the cases, in order to achieve effective disease control, neoadjuvant chemotherapy is given prior to surgical debulking. In spite of aggressive treatment approaches, most women with AOC are likely to die with chemotherapy resistant disease and identifying these patients is key, since this may allow early treatment modifications, avoiding prolonged treatment with futile toxic chemotherapy regimens. This project will focus on two roles of F-18 Fluorodeoxyglucose (FDG) PET: (a) to evaluate early response of AOC to chemotherapy and (b) as an independent prognostic indicator. Our proposal is the first such study using serial FDG PET scans with quantitative approaches using kinetic analysis to accurately evaluate treatment response in patients with AOC undergoing neoadjuvant chemotherapy and correlating it with biomarkers of tumor aggressiveness and drug resistance in evaluating treatment resistance and response. The specific aims are: (1) Correlate the changes in FDG uptake from serial FDG scans with early treatment response and clinical endpoints; (2) Determine the association between FDG PET measure of glycolysis and biomarkers of chemoresistance and tumor burden (serum CA125 levels) and correlate with defined clinical endpoints; Using serial FDG scans (FDG 2 & 3) taken during the course of neoadjuvant chemotherapy, we will determine if patients who show a significant decrease in FDG uptake will have a better and longer lasting response to treatment. The last FDG scan (FDG PET #3) will help in evaluating non-responsive disease and help direct tissue sampling at the time of surgery. We will also investigate the role of quantitative measures such as the metabolic rate of FDG (Ki) vis-à-vis semi-quantitative specific uptake value (SUV) measure in the prognostic evaluation of AOC patients. We will correlate FDG uptake with tissue and molecular markers of chemoresistance in characterizing tumor aggressiveness, drug resistance and treatment response in these patients. The results from this pilot study will establish the role for FDG PET in assessing treatment response in AOC patients receiving neoadjuvant chemotherapy. Early identification of lack of treatment response along with bio-molecular markers of tumor aggressiveness and drug resistance will help create a profile for non-responders and design studies that allow introduction of alternative treatment regimens for non-responders. This will lay the foundation for future large-scale studies and more rational treatment selection to improve survival in patients with AOC.
Project Description: Project Title: FDG PET and Biomarkers in Treatment Response in Advanced Ovarian Cancer. Project Description: The goal of this project is to evaluate the role of F-18 fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and its ability to predict early treatment response and to correlate with bio-molecular markers of chemoresistance in patients with advanced epithelial ovarian cancer (AOC). This project will focus on two roles of FDG PET: (a) to evaluate early response of AOC to chemotherapy and (b) as an independent prognostic indicator to predict chemoresistance. In this work, we will use serial FDG PET scans with quantitative approaches using kinetic analysis to accurately evaluate FDG uptake in tumors pre and post treatment, to evaluate response in patients with AOC undergoing neoadjuvant chemotherapy and to correlate it with biomarkers of tumor aggressiveness and drug resistance. Many of these biomarkers themselves may be targets for novel therapeutic agents in these patients. Project Status: - Funding start date-June 15, 2009. - The full Institution Review Board (IRB) application and the radiation safety application were finalized and submitted the 3rd week of July, 2009. Applications are currently under review. - Patient accrual will be initiated once we obtain IRB and radiation safety approval. - A patient care coordinator/data manager was hired and began work the 4th week of July, 2009; and recently completed all required training programs. - Two study kick off meetings were held with investigators to coordinate study start-up logistics. - CART software was purchased. The software will be used to develop a clinical decision-tree that we hope will personalize therapy for future cancer patients. - We started development of the study database; and also the study protocols. Sub-contracts: - University of Washington finalized and sent the award sub-contract to Philips Medical Systems the 2nd week of September 2009.
Jobs Summary: ASSOC PROFESSOR WITHOUT TENURE-Requires a record of substantial success in both teaching and research, except that in unusual cases an outstanding record in one of these activities may be considered sufficient. ASST PROFESSOR WITHOUT TENURE-Requires a demonstration of teaching and research ability beyond that ordinarily required of an instructor. Faculty members WOT are funded by a variety of sources with a focus on research activities. PROFESSOR WITHOUT TENURE-Requires outstanding, mature scholarship and research as evaluated in terms of national or international recognition, and evidenced by accomplishments in full range of academic responsibilities. PROFESSOR-Requires outstanding, mature scholarship and research as evaluated in terms of national or international recognition, and evidenced by accomplishments in full range of academic responsibilities. RESEARCH COORDINATOR-Under dir. of a PI, provide overall coord of a research project. Assist in developing research designs, data collection methods and strategies for data management, incl prep of reports/proposals. RESEARCH STUDY COORDINATOR 2-Provide support for clinical, biomedical and/or behavioral science research studies involving human subjects; develop and verify investigative procedures and assist in experimental design. (Total jobs reported: 1)
Project Status: Less Than 50% Completed
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