Can sound waves replace the scalpel for breast cancer?

NCT ID NCT01620359

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are testing whether a device called ExAblate MRgFUS can safely and completely destroy small breast cancers using focused ultrasound waves guided by MRI. The trial enrolls women with a single invasive breast tumor smaller than 2 centimeters who are already scheduled for surgery. The goal is to see if this non-invasive approach can ablate the entire tumor plus a safety margin, and whether MRI can accurately confirm the destruction.

What this could mean

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

Active substance
ExAblate MRgFUS, a device that uses focused ultrasound waves guided by MRI to heat and destroy breast cancer tissue
What this could lead to
If successful, this could offer a non-surgical option for treating small breast cancers, potentially reducing the need for lumpectomy or mastectomy.
What could go wrong
This is an early-phase trial with only 14 participants, so results may not apply broadly. Risks include incomplete tumor destruction, skin burns, or damage to nearby 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

14 people

The number who actually took part.

Started

Nov 2010

Finished

Apr 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Women age 18 years with invasive breast cancer 2. Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter 3. Lesion clearly seen on contrast-enhanced MR and in a treatable location 4. Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy 5. Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer 6. Patient with clinical Stage I disease: T1 M0 N0 7. Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits. Exclusion Criteria: 1. Invasive lobular carcinoma; 2. DCIS without invasive components on core biopsy; 3. Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate. 4. Prior XRT or ablative therapy to the target breast; 5. Patients currently receiving anticoagulation therapy within the previous 14 days; 6. Lesions difficult to target (\<1 cm from skin, nipple or the rib cage), as visualized on pre-therapy MRI; 7. Microcalcifications as the only sign of breast cancer on imaging studies; 8. Extensive intraductal components (EIC) on core biopsy. 9. Patients with breast implants; 10. Patients with prior surgical clips or other markers at the site of the breast tumor; 11. Patients with severe cerebrovascular disease (multiple CVA or CVA within 6 months); 12. hemolytic anemia (hematocrit \< 30); 13. Pregnant or lactating, post-partum women; 14. Patient overall health status of ASA \>2 15. Patient with active and ongoing infection at any body site; 16. Poor blood glucose control. 17. Severe hypertension 18. Patients with unstable cardiac status 19. Contraindication to MR or ExAblate ablation therapy 20. Patient with history of deep vein thrombosis 21. With history of pulmonary embolism; 22. Patient with sleep apnea; 23. Patient with airway problems; 24. Patient with severe claustrophobia; 25. Patient with non-MRI compatible implanted metal devices; 26. Patient with difficulty lying prone and still for up to 3 hours (180 minutes) in the MR unit; 27. Patient who cannot fit comfortably in the magnet or patients \>250 lbs; 28. Patient with prior reaction to contrast agent; 29. Patient with history of grand mal seizures; 30. Patient with severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or who is on dialysis;

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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

  • Marienhospital

    Bottrop, 46236, Germany

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