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Sound waves vs. breast cancer: no scalpel needed?

NCT ID NCT03342625

Disease control 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether high-intensity focused ultrasound (HIFU) can destroy breast tumors without surgery. Fifteen women with small, early-stage breast cancers will receive HIFU before their planned surgery. The main goal is to see if the ultrasound completely kills the tumor cells, with success measured by lab analysis of the removed tissue.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

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. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression. 2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound. 3. Clinical N0. 4. Bra cup size greater than or equal to B. 5. Markable and identifiable lesion in MRI. 6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery. 7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination. 8. No contraindication to MRI. Exclusion Criteria : 1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ. 2. Bilateral lesion. 3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound. 4. Unifocal palpable tumor. 5. Cup size bra equal to A. 6. Cutaneous lesion on the breast to be treated by HIFU. 7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour. 8. Pregnant or postpartum patient. 9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.

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Conditions

The condition(s) this trial relates to.

female breast carcinoma invasive ductal breast carcinoma

As listed by the trial registrant

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

Breast cancer female

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

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