High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and B… (NCT07384078) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Finland294 participantsStarted 2026-04-01
Plain-language summary
This prospective, randomized, controlled, and single-blinded non-inferiority clinical trial compare the efficacy and tolerability of high intensity focused ultrasound (HIFU) to standard cryotherapy in the treatment of low-risk basal cell carcinomas (BCCs) and Bowen's disease (BD) in adults. The main questions it aims to answer are:
* Is HIFU an efficient treatment option for BCCs and BD?
* What medical problems do participants get after HIFU?
Researchers will compare HIFU to standard cryotherapy with liquid nitrogen to see if the ultrasound works to treat these local and low-risk non-melanosytic skin cancers.
Participants will:
* Be treated either with HIFU (intervention) or cryotherapy (control).
* Visit the clinic 4 weeks, 1-, 3- and 5 years after the treatment for check-ups, tests and survey questions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 18 years or older at the time of informed consent
* ability to give informed consent and comply with the treatment protocol and follow-up plan
* study lesion located between neck and knees
* one of following histologically confirmed diagnosis: Superficial BCC with maximum diameter of 2.0 cm / Nodular BCC with max. diameter of 1.5 cm / BD with max. diameter of 2.0 cm
Exclusion Criteria:
* Study lesion location in face, head, genitals, hands, or below the knee
* Clinical/dermoscopical/histological feature for high-risk/aggressive BCC
* Clinical/histological sign for hypertrophic BD
* Clinical/dermoscopical/histological feature for Squamous cell carcinoma
* Gorlin Golz syndrome
* Pregnancy or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment efficacy
Timeframe: From treatment to the end of follow up at 5 years