PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

NCT ID: NCT00236275

Last Updated: 2011-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-12-31

Brief Summary

Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI

Detailed Description

PET/CT with FDG-(18F) and FLT-(18F) and MRI are performed at the initial staging, 3 times during sequential adjuvant chemotherapy and prior to surgery, aiming to find the most efficient modality to predict the response to neoadjuvant chemotherapy of the primary breast cancer and its possible lymph node metastases. Post-surgical histology and a 6 month follow-up (to detect occult metastases) will constitute the standard of truth for determination and comparison of diagnostic performances.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Fluoro-L-thymidine-(18F)

Group Type: EXPERIMENTAL

Fluoro-L-thymidine-(18F)

Intervention Type: DRUG

Fluoro-L-thymidine-(18F)

Interventions

Fluoro-L-thymidine-(18F)

Fluoro-L-thymidine-(18F)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery

Exclusion Criteria

• Indicated chemotherapy without that a curative tumorectomies is foreseen(planned)
• Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG
• Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes)
• Diabetic waits
• Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations
• Patient not having given her lit(enlightened) assent
• Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol)
• Of less than 18 years old or pregnant patient.
• Breast cancer stage(stadium) IV
• Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j.
• In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of developpement

Principal Investigators

Jean-Noël TALBOT, Pr,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital TENON

Paris, , France

Countries

France

Other Identifiers

P020907

Identifier Type: -

Identifier Source: org_study_id