Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
NCT ID: NCT00904410
Last Updated: 2012-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2005-05-31
2008-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
FDG-PET
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
Interventions
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FDG-PET
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* Inflammatory breast cancer (T4d)
* Diabetic patients unbalanced (glycemia\>1.40)
* Pregnant or lactating women
18 Years
FEMALE
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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GAUTHIER Helene
Role: STUDY_CHAIR
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Countries
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Other Identifiers
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CHIMTEP 0402
Identifier Type: -
Identifier Source: org_study_id