Trials / Completed
CompletedNCT02553967
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Centre Oscar Lambret · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Functional MRI | Functional MRI |
Timeline
- Start date
- 2016-01-07
- Primary completion
- 2019-11-25
- Completion
- 2021-04-15
- First posted
- 2015-09-18
- Last updated
- 2026-03-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02553967. Inclusion in this directory is not an endorsement.