Clinical trial NCT05698706: High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma
Official title: High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: Skin cancer
HIFU
BCC
Dermatology
High Intensity Focused Ultrasound
Dermoscopy
Lead sponsor: Old Town Clinic, Poland
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Cure rate
timeFrame: 3 months
measure: Severity of short term adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Severity of adverse events
timeFrame: 12 months
measure: Cure rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Old Town Clinic
Study officials:
affiliation: Old Town Clinic
name: Jacek Calik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bove T, Zawada T, Serup J, Jessen A, Poli M. High-frequency (20-MHz) high-intensity focused ultrasound (HIFU) system for dermal intervention: Preclinical evaluation in skin equivalents. Skin Res Technol. 2019 Mar;25(2):217-228. doi: 10.1111/srt.12661. Epub 2019 Jan 8.
citation: Soegaard S, Aarup V, Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound system for dermal intervention: A 12-week local tolerance study in minipigs. Skin Res Technol. 2020 Mar;26(2):241-254. doi: 10.1111/srt.12786. Epub 2019 Sep 20.
citation: Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Skin Res Technol. 2020 Nov;26(6):824-831. doi: 10.1111/srt.12883. Epub 2020 Jun 17.
citation: Calik J, Zawada T, Bove T. Treatment of superficial benign vascular tumors by high intensity focused ultrasound: Observations in two illustrative cases. J Cosmet Dermatol. 2022 Aug;21(8):3371-3379. doi: 10.1111/jocd.14682. Epub 2021 Dec 17.
citation: Calik J, Migdal M, Zawada T, Bove T. Treatment of Seborrheic Keratosis by High Frequency Focused Ultrasound - An Early Experience with 11 Consecutive Cases. Clin Cosmet Investig Dermatol. 2022 Jan 28;15:145-156. doi: 10.2147/CCID.S348106. eCollection 2022.