NCT01712815

PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. Study fludeoxyglucose \[18F\] 2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine ) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite, tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1 minute and then undergo PET/CT scan at baseline. Patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment. After completion of study treatment, patients are followed up at 24 hours.

Conditions

• HER2-positive Breast Cancer
• Recurrent Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	questionnaire administration	Ancillary studies
RADIATION	fluorine F 18-clevudine	Undergo fluorine F 18-clevudine PET/CT scan
PROCEDURE	positron emission tomography/computed tomography	Undergo fluorine F18-clevudine PET/CT scan

Timeline

• Start date: 2013-11-22
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2012-10-24
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States