Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET (CHIMTEP)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET|
- Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy [ Time Frame: before and 3 weeks after 1st cycle ] [ Designated as safety issue: Yes ]
- Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy [ Time Frame: 3 weeks after the 3rd cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||January 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904410
|Centre Oscar Lambret|
|Lille, France, 59020|
|Study Chair:||GAUTHIER Helene||Centre Oscar Lambret|