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Focused ultrasound breast tumor trial withdrawn before starting

NCT ID NCT01827969

Knowledge-focused Sponsor: Institut Bergonié Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study planned to test whether MRI-guided focused ultrasound could destroy breast tumors before mastectomy. The procedure was to be done under local anesthesia and sedation. However, the trial was withdrawn before enrolling any participants, so no results are available.

What this could mean

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

Active substance
ablathermy focused ultrasound

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.

Start date

Dec 2009

Finished

Mar 2011

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: * Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-2. * Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications * Lesion recognizable and identifiable in MRI * Indication of mastectomy with or without axillary * Lesion located more than 10 mm from the skin, the nipple and pectoralis major * No cons-indication to MRI (pacemaker) * Women whose age is ≥ 18 years * If premenopausal patient: patient contraceptives * Patient has signed informed consent * Affiliation to a social security scheme Exclusion Criteria: * Tumor-TD T4B classified or non-palpable lesion * If age \<70 years: no indication of adjuvant chemotherapy and neoadjuvant * MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter * Inability to hold still in the prone position, arms extended, for 30 minutes * Contraindication to MRI * Patient deprived of liberty and major subject of a measure of legal protection or unable to consent * Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

Breast tumor

Contacts and locations

Locations

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000, France

More trials for these conditions

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