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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Fluoro-L-thymidine-(18F)

Study type

Interventional

Funder types

Other

Identifiers

NCT00236275

P020907

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.