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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Fluoro-L-thymidine-(18F)

• Registration Number: NCT00236275
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-12
• Status Verified: 2007-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fluoro-L-thymidine-(18F)	Fluoro-L-thymidine-(18F)

Primary Outcome Measures

Name	Time	Method
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy	during de study	Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy

Trial Locations

Locations (1)

Hôpital TENON; 🇫🇷 Paris, France