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

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: Breast Cancer
• Intervention / Treatment: Device: Functional MRI

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	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.	6 months
Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.	6 months
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.	6 months

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: University Hospital, Lille
• Investigators: Principal Investigator: Claudia REGIS, MD, Centre Oscar Lambret

Study record dates

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 (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: functional Magnetic Resonance Imaging (fMRI); Breast reconstructive surgery; Breast Q questionnaire
• Other Study ID Numbers: REMASCO-1503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO