HIFU for Treatment of Non-nodular and Recurrent BCC

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Basal Cell

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 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.

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: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Areas with de-novo or recurrent BCC<br>Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound. | Device: TOOsonix system ONE-M<br>* All selected BCC areas will be treated by 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 | 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 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 1) to Severe side effects (score 4). | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basal cell carcinoma, BCC, Skin cancer, High intensity focused ultrasound, HIFU, Dermatology