Breast Cancer
Conditions
Keywords
adenocarcinoma, breast
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
Interventions
OTHERFDG-PET
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
Sponsors
Centre Oscar Lambret
Ministry of Health, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* T\<2cm * Inflammatory breast cancer (T4d) * Diabetic patients unbalanced (glycemia\>1.40) * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy | before and 3 weeks after 1st cycle |
Secondary
| Measure | Time frame |
|---|---|
| Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy | 3 weeks after the 3rd cycle |
Countries
France
Contacts
STUDY_CHAIRGAUTHIER Helene
Centre Oscar Lambret
Outcome results
None listed