Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET (CHIMTEP)

Centre Oscar Lambret

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Other: FDG-PET

Study type: Interventional

Funder types: Other

Identifiers

NCT00904410

CHIMTEP 0402

Details and patient eligibility

About

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.

Full description

Further study details as provided by Centre Oscar Lambret

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

1

Experimental group

Treatment:

Other: FDG-PET