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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00904410
First received: March 15, 2007
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Other: FDG-PET
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: May 2005
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: FDG-PET
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle

Detailed Description:

Further study details as provided by Centre Oscar Lambret

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00904410

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Ministry of Health, France
Investigators
Study Chair: GAUTHIER Helene Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00904410     History of Changes
Other Study ID Numbers: CHIMTEP 0402
Study First Received: March 15, 2007
Last Updated: July 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
adenocarcinoma
breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014