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

Breast Cancer Clinical Trial

— CHIMTEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904410
• Other study ID #: CHIMTEP 0402
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2007
• Last updated: July 20, 2012
• Start date: May 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Further study details as provided by Centre Oscar Lambret

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• FDG-PET
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy		before and 3 weeks after 1st cycle	Yes
Secondary	Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy		3 weeks after the 3rd cycle	Yes