NCT02553967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 7, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

September 17, 2015

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Keywords

functional Magnetic Resonance Imaging (fMRI)Breast reconstructive surgeryBreast Q questionnaire

Outcome Measures

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.

    6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Immediate breast reconstruction

EXPERIMENTAL

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

Device: Functional MRI

Secondary breast reconstruction

EXPERIMENTAL

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

Device: Functional MRI

Interventions

Functional MRIDEVICE

Functional MRI

Immediate breast reconstructionSecondary breast reconstruction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Claudia REGIS, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

January 7, 2016

Primary Completion

November 25, 2019

Study Completion

April 15, 2021

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)