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

March 16, 2026 updated by: Centre Oscar Lambret

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate breast reconstruction
  • Total mastectomy + immediate reconstructive surgery
  • 6 months after surgery : Functional MRI and questionnaires
Device: Functional MRI
Functional MRI
Experimental: Secondary breast reconstruction
  • Within 2 months before surgery : Functional MRI
  • Reconstructive surgery
  • 6 months after surgery : Functional MRI and questionnaires
Device: Functional MRI
Functional MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the breast reconstructed using an autologous flap and a prosthesis.
Time Frame: 6 months
6 months
BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the mastectomy scar before reconstruction.
Time Frame: 6 months
6 months
Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.
Time Frame: 6 months
6 months
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

University Hospital, Lille

Investigators

  • Principal Investigator: Claudia REGIS, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2016

Primary Completion (Actual)

November 25, 2019

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimated)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMASCO-1503
  • 2015-A00226-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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