Breast CancerREMASCONCT02553967
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
A study testing Functional MRI in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Functional MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2016to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Functional MRI
- Keywords
- functional Magnetic Resonance Imaging (fMRI), Breast reconstructive surgery, Breast Q questionnaire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIDevice
Functional MRI
| Study group | Role | What they receive |
|---|---|---|
| Immediate breast reconstruction | Experimental | * Total mastectomy + immediate reconstructive surgery
* 6 months after surgery : Functional MRI and questionnaires Receives: Device: Functional MRI |
| Secondary breast reconstruction | Experimental | * Within 2 months before surgery : Functional MRI
* Reconstructive surgery
* 6 months after surgery : Functional MRI and questionnaires Receives: Device: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.
Measured: 6 months
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start7 Jan 2016
- Primary completion25 Nov 2019
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Claudia REGIS, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553967
- Sponsor's protocol ID
- REMASCO-1503
- Other IDs
- 2015-A00226-43
- Acronym
- REMASCO
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2015
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
- ClinicalTrials.gov ID
- NCT02553967
- Acronym / sponsor ID
- REMASCO / REMASCO-1503
- Conditions
- Breast Cancer
- Keywords
- functional Magnetic Resonance Imaging (fMRI), Breast reconstructive surgery, Breast Q questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate breast reconstruction | Experimental | Device: Functional MRI* Total mastectomy + immediate reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires |
| Secondary breast reconstruction | Experimental | Device: Functional MRI* Within 2 months before surgery : Functional MRI * Reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRIFunctional MRI | Device | Immediate breast reconstruction, Secondary breast reconstruction |
Primary outcome
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
4 secondary outcomes
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
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
Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.
Time frame: 6 months
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia REGIS, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.