Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO) (NCT02553967) | Clinical Trial Compass
CompletedNot Applicable
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
France49 participantsStarted 2016-01-07
Plain-language summary
Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.
The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, Or patient undergoing a unilateral secondary breast reconstruction
✓. WHO performance status less than or equal to 2
✓. Age ≥ 18 years
✓. For patients of childbearing age, use of an effective contraceptive method for the duration of the study
✓. Patient having been informed and having signed an informed consent form for the study.
Exclusion criteria
✕. Patient undergoing a breast reconstruction by exclusive lipomodelling
✕. Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves
✕. Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards
✕
What they're measuring
1
BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the non-operated breast.