Clinical trial · Interventional
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Functional MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate breast reconstruction
- description
- * Total mastectomy + immediate reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires
- interventionNames
- Device: Functional MRI
- type
- EXPERIMENTAL
- label
- Secondary breast reconstruction
- description
- * Within 2 months before surgery : Functional MRI * Reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires
- interventionNames
- Device: Functional MRI
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. WHO performance status less than or equal to 2 3. Age ≥ 18 years 4. For patients of childbearing age, use of an effective contraceptive method for the duration of the study 5. Patient having been informed and having signed an informed consent form for the study. Exclusion Criteria: 1. Patient undergoing a breast reconstruction by exclusive lipomodelling 2. Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves 3. Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards 4. History of brain surgery 5. History of contralateral breast surgery 6. History of prophylactic total mastectomy 7. Reconstruction techniques using a mixed procedure (autologous + prosthesis) 8. Patient on medication that may alter the BOLD signal in MRI 9. Pregnant or breastfeeding women 10. Patient under tutorship or guardianship
References
Publications (0)
Data not yet available