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

Assistance Publique - Hôpitaux de Paris1 site in 1 country60 target enrollmentMay 2004

ConditionsBreast Cancer

InterventionsFluoro-L-thymidine-(18F)

DrugsFluoro-L-thymidine-(18F)

Overview

Phase: Phase 3
Intervention: Fluoro-L-thymidine-(18F)
Conditions: Breast Cancer
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 60
Locations: 1
Primary Endpoint: Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

December 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

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.