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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Functional MRI

• Registration Number: NCT02553967
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2016-01-07
• Primary Completion: 2019-11-25
• Study Completion: 2021-04-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate breast reconstruction	Functional MRI	* Total mastectomy + immediate reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires
Secondary breast reconstruction	Functional MRI	* Within 2 months before surgery : Functional MRI * Reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.	6 months
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

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France