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Spots Global Cancer Trial Database for Quantitative Imaging Biomarkers for Sarcoma

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Trial Identification

Brief Title: Quantitative Imaging Biomarkers for Sarcoma

Official Title: Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients

Study ID: NCT02579980

Conditions

Sarcoma

Study Description

Brief Summary: Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow visualization of how sarcomas are different from the normal organs of the body. These MRI tests will tell us the location of sarcoma and its proximity to other structures, as well as correlation of imaging with pathological characteristics after surgery

Detailed Description: Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI) are imaging approaches that are being utilized in preclinical evaluation as well as clinical trials. DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. Evidence of drug efficacy and dose-dependent response has been demonstrated with certain angiogenesis inhibitors. It may also provide useful information for identifying early disease progression, independent of the treatment modality. While these approaches provide additional functional information, they have yet to be validated in sarcoma patients. This study seeks to develop a standardized protocol for performing DCE-MRI and DW-MRI and implement this in a clinical trial of patients with sarcomas who will have surgical resection as part of their standard care. This will allow the accuracy of in vivo MRI measurements to be directly compared to histology as ground truth. The study will also determine the reproducibility of these techniques using repeat baseline imaging as well as evaluate the quantitative changes in these parameters before and after therapy and correlate with histopathology. The collaboration between Columbia University and the University of Utah for this project will allow the existing quantitative MRI approaches to be expanded to a multi-center setting, and will establish a paradigm infrastructure for future expansion to larger scale multi-center therapeutic trials in sarcoma.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Columbia University Medical Center, New York, New York, United States

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

Contact Details

Name: Lawrence H Schwartz, MD

Affiliation: James Picker Professor and Chairman Department of Radiology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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