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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00904410
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : July 23, 2012
Ministry of Health, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:

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

Detailed Description:
Further study details as provided by Centre Oscar Lambret

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy [ Time Frame: before and 3 weeks after 1st cycle ]

Secondary Outcome Measures :
  1. Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy [ Time Frame: 3 weeks after the 3rd cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00904410

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Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Ministry of Health, France
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Study Chair: GAUTHIER Helene Centre Oscar Lambret
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Responsible Party: Centre Oscar Lambret Identifier: NCT00904410    
Other Study ID Numbers: CHIMTEP 0402
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012
Keywords provided by Centre Oscar Lambret:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases