HIFU for Treatment of Non-nodular and Recurrent BCC

Carcinoma, Basal Cell Clinical Trial

— BCC-HIFU2101  

Official title:

High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133427
• Other study ID #: CIV-21-06-037051
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Bispebjerg Hospital
• Contact: Joergen V Serup, Professor
• Phone: +45-2142 4888
• Email: Joergen.Vedelskov.Serup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

Device:
• TOOsonix system ONE-M
All selected BCC areas will be treated by high intensity focused ultrasound

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Hovedstaden
Denmark	Roskilde Hospital	Roskilde	Sjaelland

Sponsors (2)

Lead Sponsor	Collaborator
Joergen Serup	Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Severity of adverse events	Any objective adverse effect or event, local or systemic, related to the treatment and the investigational device (wound and course of wound healing, scar formation, instrumental hazards) measured at 6, 9 and 12 months. Measured on a 4-point severity score ranging from No side effects (score 1) to Severe side effects (score 4).	12 months
Secondary	Cure Rate	Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device measured at 6, 9 and 12 months. Measured as a binary Yes/No output.	12 months