Spots Global Cancer Trial Database for Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
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Trial Identification
Brief Title: Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
Official Title: 3'-Deoxy-3'-18F Fluorothymidine PET/CT in Predicting Response To Chemotherapy Before Surgery in Patients With Locally Advanced Breast Cancer
Study ID: NCT00572728
Study Description
Brief Summary: This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
Detailed Description: PRIMARY OBJECTIVES: I. To correlate the percentage change in standardized uptake value at 60 minutes (SUV60) between baseline (FLT-1) and early-therapy (FLT-2) with pathologic complete response to neoadjuvant chemotherapy of the primary tumor in patients with locally advanced breast cancer. SECONDARY OBJECTIVES: I. To demonstrate correlation between FLT-1 and post-therapy (FLT-3) uptake parameters and tumor proliferation markers in locally advanced breast cancer. II. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response of the primary tumor and residual cancer burden (RCB). III. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and non-response of the primary tumor (stable or progressive disease) to therapy. IV. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response to neoadjuvant chemotherapy in patients with regional disease in the lymph nodes in patients with locally advanced breast cancer. V. To compare the changes of FLT-2 and FLT-3 uptake parameters to changes in tumor sizes from other serial imaging modalities such as mammograms, magnetic resonance imaging (MRI), and ultrasound. VI. To compare the changes of FLT-2 and FLT-3 uptake parameters to metabolic changes from \[18F\] fludeoxyglucose (FDG)-PET, as available. VII. To continue to monitor for potential safety issues and define any physiologic effects associated with 18F FLT administration. OUTLINE: Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scottsdale Medical Imaging Limited, Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Morton Plant Hospital, Clearwater, Florida, United States
Morton Plant Mease, Dunedin, Florida, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mount Sinai Medical Center, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Radiology Consultants Inc, Youngstown, Ohio, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
American College of Radiology Imaging Network, Philadelphia, Pennsylvania, United States
Hospital of The University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Excel Diagnostics, Houston, Texas, United States
Westchase Oncology Center, Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: Lale Kostakoglu
Affiliation: American College of Radiology Imaging Network
Role: PRINCIPAL_INVESTIGATOR
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