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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 17, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT00904410). This is a study registration, not published results. Lead sponsor: Centre Oscar Lambret. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 63 participants (ACTUAL). Conditions: Breast Cancer. Interventions: OTHER: FDG-PET. Primary outcome measures: Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy , before and 3 weeks after 1st cycle. Brief summary: 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches. We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients. Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy. The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.