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Brain scans reveal how women perceive reconstructed breasts

NCT ID NCT02553967

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study used functional MRI (fMRI) to see how the brain's sensory map changes after breast reconstruction in women treated for breast cancer. Researchers compared brain activity when touching the reconstructed breast versus the natural breast. The goal was to objectively measure sensory recovery, not to test a treatment. 49 women participated, and the study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors understand how the brain adapts after breast reconstruction, potentially improving surgical techniques and patient satisfaction.
What could go wrong
This is a small, completed observational study (49 participants) using fMRI, not a treatment trial. Results may not apply to all patients or lead to direct clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

49 people

The number who actually took part.

Started

Jan 2016

Finished

Apr 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Oscar Lambret

    Lille, 59020, France

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Other studies related to the condition(s) this trial covers.