Trial | NCT00236275  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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
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 Started
May 31
2004
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2007
Last Update
May 02
2011
Estimate

Drug Fluoro-L-thymidine-(18F)

Fluoro-L-thymidine-(18F)

1 Experimental

Fluoro-L-thymidine-(18F)

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.
No Results Posted