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Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO) — REMASCO  

Breast Cancer Clinical Trial

Official title:
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

Clinical Trial 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.

Clinical Trial Description

Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to. Immediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form. Secondary breast reconstruction group : - In the two months preceding the surgery, a preoperative fMRI will be performed. - Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02553967
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Completed
Phase N/A
Start date January 7, 2016
Completion date April 15, 2021
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