HIFU for Treatment of Non-nodular and Recurrent BCC

NCT05133427 | Active Not Recruiting

• 1 other identifier: CIV-21-06-037051
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Basal cell carcinoma; BCC; Skin cancer; High intensity focused ultrasound; HIFU; Dermatology

Outcome Measures

Primary Outcomes (2)

• Cure Rate

  Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured as a binary Yes/No output.

  3 months

• Severity of short term treatment side effects

  Safety profile after treatment of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured on a 4-point severity score ranging from No side effects (score 1) to Severe side effects (score 4).

  3 months

Secondary Outcomes (2)

• Severity of adverse events

  12 months

• Cure Rate

  12 months

Study Arms (1)

Areas with de-novo or recurrent BCC

EXPERIMENTAL

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

Device: TOOsonix system ONE-M

Interventions

TOOsonix system ONE-M DEVICE

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

Areas with de-novo or recurrent BCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joergen Serup: lead
• Zealand University Hospital: collaborator

Study Sites (2)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Roskilde Hospital

Roskilde, Region Sjælland, 4000, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician, Department of Dermatology

Model Details: The study is a multicenter (two-center), open-label study in humans (hospital outpatients). The study is not comparative with respect to the two study groups; however, it is aimed to pool data if the study groups are statistically comparable. The investigation is performed prior to CE mark to confirm safety and performance of the System ONE-M device when used as intended, i.e. as an non-invasive method to remove non-nodular basal cell carcinoma by 20 MHz high intensity focused ultrasound.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 24, 2021
• Study Start: March 21, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)