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Completed

NCT Number: NCT02553967

Breast Reconstruction and Body Map : Assessment by Functional MRI (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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • WHO performance status less than or equal to 2
  • Age ≥ 18 years
  • For patients of childbearing age, use of an effective contraceptive method for the duration of the study
  • Patient having been informed and having signed an informed consent form for the study.

Exclusion criteria

  • Patient undergoing a breast reconstruction by exclusive lipomodelling
  • Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves
  • Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards
  • History of brain surgery
  • History of contralateral breast surgery
  • History of prophylactic total mastectomy
  • Reconstruction techniques using a mixed procedure (autologous + prosthesis)
  • Patient on medication that may alter the BOLD signal in MRI
  • Pregnant or breastfeeding women
  • Patient under tutorship or guardianship

Treatment and study plan

Functional MRI

Device

Functional MRI

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.

    Time frame: 6 months

  4. Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • University Hospital, Lille

Registry information

Acronym: REMASCO

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Sep 18, 2015
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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