Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
Phase 4
Completed
- Conditions
- Breast Cancer
- Interventions
- Other: FDG-PET
- Registration Number
- NCT00904410
- Lead Sponsor
- Centre Oscar Lambret
- 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.
- Detailed Description
Further study details as provided by Centre Oscar Lambret
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 63
Inclusion Criteria
- Age > 18
- Breast cancer treated by neo-adjuvant chemotherapy (T>2cm)
- Measurable lesions ,assessed clinically and by ultrasound
- Delay minimum between biopsy and PET: 15 days
- PS-WHO: 0
Exclusion Criteria
- T<2cm
- Inflammatory breast cancer (T4d)
- Diabetic patients unbalanced (glycemia>1.40)
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 FDG-PET -
- Primary Outcome Measures
Name Time Method Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy before and 3 weeks after 1st cycle
- Secondary Outcome Measures
Name Time Method Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy 3 weeks after the 3rd cycle
Trial Locations
- Locations (1)
Centre Oscar Lambret
🇫🇷Lille, France