Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Inflammatory breast cancer (T4d)
- •Diabetic patients unbalanced (glycemia>1.40)
- •Pregnant or lactating women
Arms & Interventions
1
Intervention: FDG-PET (Other)
Outcomes
Primary Outcomes
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
Time Frame: before and 3 weeks after 1st cycle
Secondary Outcomes
- Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy(3 weeks after the 3rd cycle)