NCT00534274

Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer. PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

Detailed description

OBJECTIVES: Primary * Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (\^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer. * Correlate PET-\^18F-FLT results with histological response. Secondary * Evaluate the correlation of early changes in tumor uptake of \^18F-FLT after the first course of chemotherapy with complete response after treatment completion. * Evaluate the correlation of early changes in tumor uptake of \^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy. * Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy. * Determine if initial intensity of tumor uptake of \^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy. * Determine if the tumor uptake of \^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy. * Evaluate the role of TK1 on the kinetics of \^18 F-FLT. * Analyze serum. * Research biomarkers of genomics, transcription, and proteomics. * Evaluate the toxicity of \^18F-FLT. OUTLINE: This is a multicenter study. Patients receive 3'-deoxy-3'-(18F) fluorothymidine (\^18F-FLT) IV and undergo positron emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy. Patients receiving bisequential chemotherapy undergo \^18F-FLT-PET before the change in drugs (usually the fourth or fifth course). All patients undergo a final \^18F-FLT-PET after the last chemotherapy course but before surgery. After completion of study therapy, patients are followed for 1 month.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	3'-deoxy-3'-[18F]fluorothymidine

Timeline

• Start date: 2006-11-01
• Primary completion: 2012-04-01
• Completion: 2013-09-01
• First posted: 2007-09-24
• Last updated: 2014-12-16

Locations

24 sites across 1 country: France