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Completed

NCT Number: NCT00904410

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

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

Further study details as provided by Centre Oscar Lambret

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG-PET

Other

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

Primary outcomes

  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 outcomes

  1. Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy

    Time frame: 3 weeks after the 3rd cycle

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: CHIMTEP

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
May 19, 2009
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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