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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

Interventions

CT
18F-FLT
PET

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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