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Sound waves zapping skin cancer? new trial tests HIFU for basal cell carcinoma

NCT ID NCT05133427

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new device that uses high-intensity focused ultrasound (HIFU) to treat basal cell carcinoma, the most common skin cancer. Forty adults with either new or recurring skin cancers will receive a single 3-5 minute treatment. Researchers will check if the cancer is gone after 3 months and monitor side effects for one year.

What this could mean

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

Active substance
High-intensity focused ultrasound (HIFU) device
What this could lead to
If successful, this could offer a quick, non-invasive treatment for common skin cancers without surgery.
What could go wrong
This is a small early-stage trial with only 40 people. The treatment may not fully remove the cancer or could cause side effects like scarring.

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 40 people

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

Started

Mar 2022

Expected to finish

Dec 2026

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

Anyone

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: * Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age. * Subjects who have received oral and written study information, accepted participation and signed the informed consent document. * Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions. * Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications. * Subjects, who have histologically and clinically verified basal cell carcinoma either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included. Exclusion Criteria: * Subjects who are less than 18 years at the time of informed consent. * Subject is pregnant or lactating at time of first treatment * Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure. * Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons * Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer. * Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment. * Subjects with abnormal scar formation * Subjects with impaired wound healing * Subjects with the basal cell carcinoma under study located nearby (\<5 cm) an implant or a site injected with a dermal filler or paraffin. * Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.

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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

  • Bispebjerg Hospital

    Copenhagen, Capital Region, 2400, Denmark

  • Roskilde Hospital

    Roskilde, Region Sjælland, 4000, Denmark

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