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
- 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.
- 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
- Determine if initial intensity of tumor uptake of ^18F-FLT varies according to
histologic type of tumor, indices of proliferation, and tumor cellularity before
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
Olivier Couturier, MD
Centre Hospitalier Regional et Universitaire d'Angers
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
FLT01 - UC-0140/0505