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

NCT ID: NCT02553967

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-07
• Study Completion Date: 2021-04-15

Brief 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

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Immediate breast reconstruction

• Total mastectomy + immediate reconstructive surgery
• 6 months after surgery : Functional MRI and questionnaires

Group Type: EXPERIMENTAL

Functional MRI

Intervention Type: DEVICE

Functional MRI

Secondary breast reconstruction

• Within 2 months before surgery : Functional MRI
• Reconstructive surgery
• 6 months after surgery : Functional MRI and questionnaires

Group Type: EXPERIMENTAL

Functional MRI

Intervention Type: DEVICE

Functional MRI

Interventions

Functional MRI

Functional MRI

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia REGIS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, , France

Countries

France

Other Identifiers

REMASCO-1503

Identifier Type: -

Identifier Source: org_study_id