Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET (CHIMTEP)
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|ClinicalTrials.gov Identifier: NCT00904410|
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : July 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: FDG-PET||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||January 2008|
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
- Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy [ Time Frame: before and 3 weeks after 1st cycle ]
- Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy [ Time Frame: 3 weeks after the 3rd cycle ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904410
|Centre Oscar Lambret|
|Lille, France, 59020|
|Study Chair:||GAUTHIER Helene||Centre Oscar Lambret|