HIFU for Treatment of Non-nodular and Recurrent BCC

NCT ID: NCT05133427

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2026-12-01

Brief Summary

The overall objective of this study is to demonstrate the safety and efficacy of removal of Basal Cell Carcinoma (BCC) using a new investigational equipment based on high-intensity focused ultrasound.

Basal cell carcinoma is the most common cancer in Europe, Australia and the U.S.A. The general upwards age shift in the population in these regions is expected to be accompanied by an increase in the incidence of this type of cancer. There are currently more the 20.000 BCC registrations in Denmark every year, and occurrences on a global scale are counted in several tens of millions per year. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective.

The investigational device used in the investigation is a Danish developed system capable of making controlled and targeted thermo-mechanical treatment of small intradermal volumes containing e.g. BCC cells, but without inflicting damage to the surrounding tissue.

The investigation involves an evaluation of the safety and efficacy profile 3 months after a single 3-5 minute treatment. Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment.

Conditions

Carcinoma, Basal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Areas with de-novo or recurrent BCC

Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound.

Group Type: EXPERIMENTAL

TOOsonix system ONE-M

Intervention Type: DEVICE

All selected BCC areas will be treated by high intensity focused ultrasound

Interventions

TOOsonix system ONE-M

All selected BCC areas will be treated by high intensity focused ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Joergen Serup

OTHER

Sponsor Role: lead

Responsible Party

Joergen Serup

Professor, Chief Physician, Department of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Roskilde Hospital

Roskilde, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

CIV-21-06-037051

Identifier Type: -

Identifier Source: org_study_id