Sound waves zapping skin cancer? new trial tests HIFU for basal cell carcinoma
NCT ID NCT05133427
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carcinoma, basal cell are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.