Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
Further study details as provided by Centre Oscar Lambret
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
Outcome Time Frame:
before and 3 weeks after 1st cycle
Safety Issue:
Yes
Principal Investigator
GAUTHIER Helene
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CHIMTEP 0402
NCT ID:
NCT00904410
Start Date:
May 2005
Completion Date:
January 2008
Related Keywords:
- Breast Cancer
- adenocarcinoma
- breast
- Breast Neoplasms
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