High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma

Study Overview
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Brief Summary
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The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. It accounts for more than 75% of all skin cancer cases in those regions. There are currently more the 14000 BCC cases registrations in Poland every year, and occurrences on a global scale are counted in several millions per year. Given the trend of aging population those numbers will only increase with time. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the study is a 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 few-minute treatment. Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment.

Official Title
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High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Device: TOOsonix System ONE-M


Participation Criteria
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Eligibility Criteria
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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 cancer of thickness not more 2.0 mm measured by ultrasound imaging or histopathological examination. 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 any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study Subjects undergoing immunosuppressive treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: De-novo BCC with thickness not more than 2.0 mm<br>Areas with de-novo BCC of thickness not more than 2.0 mm (as confirmed by ultrasound imaging or histopathological examination) will be treated by high intensity focused ultrasound | Device: TOOsonix System ONE-M<br>* Selected BCC sites will be treated using high intensity focused ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no | 3 months | 
| Severity of short term adverse events | Safety profile after treatment of basal cell carcinoma measured on a 4-point severity score ranging from No side effects (score 0) to Severe side effects (score 3) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 0) to Severe side effects (score 3) | 12 months | 
| Cure rate | Frequency of complete clearance of BCC after HIFU treatment measured at 6, 9, 12 months after HIFU treatment. Binary output: yes/no | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIFU, Skin cancer, BCC, Dermatology, High Intensity Focused Ultrasound, Dermoscopy