Clinical trial NCT00236275: PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
Official title: PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Comparison of imaging modalities
predict the effectiveness of neoadjuvant chemotherapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pierre and Marie Curie University
First posted: 2005-10-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
timeFrame: during de study
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital TENON
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Noël TALBOT, Pr,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: