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

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

NCT ID: NCT05698706

Condition: Basal Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell

Conditions: Keywords:
Skin cancer
HIFU
BCC
Dermatology
High Intensity Focused Ultrasound
Dermoscopy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: TOOsonix System ONE-M
Description: Selected BCC sites will be treated using high intensity focused ultrasound
Arm group label: De-novo BCC with thickness not more than 2.0 mm

Summary: 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.

Criteria for 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Old Town Clinic

Address:
City: Wrocław
Zip: 50-127
Country: Poland

Status: Recruiting

Contact:
Last name: Jacek Calik, MD, PhD

Phone: +48 516 222 516
Email: jacek.calik@oldtownclinic.pl

Start date: December 14, 2022

Completion date: May 14, 2025

Lead sponsor:
Agency: Jacek Calik
Agency class: Other

Source: Old Town Clinic, Poland

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05698706
https://oldtownclinic.pl/en/