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

NCT05698706 | Unknown

• 1 other identifier: HIFU-BCC-2023-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

Skin cancer; HIFU; BCC; Dermatology; High Intensity Focused Ultrasound; Dermoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Severity of adverse events

  12 months

• Cure rate

  12 months

Study Arms (1)

De-novo BCC with thickness not more than 2.0 mm

EXPERIMENTAL

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

Interventions

TOOsonix System ONE-M DEVICE

Selected BCC sites will be treated using high intensity focused ultrasound

De-novo BCC with thickness not more than 2.0 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacek Calik: lead

Study Sites (1)

Old Town Clinic

Wroclaw, 50-127, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 30620418 BACKGROUND

• 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.

  PMID: 31541524 BACKGROUND

• 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.

  PMID: 32557832 BACKGROUND

• 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.

  PMID: 34921489 BACKGROUND

• 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.

  PMID: 35125879 BACKGROUND

Related Links

• Website of Old Town Clinic

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacek Calik, MD, PhD

  Old Town Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacek Calik, MD, PhD

CONTACT

+48 516 222 516; jacek.calik@oldtownclinic.pl

Bartosz Wozniak, MD

CONTACT

+48 516 222 516

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Managing Director

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: December 14, 2022
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)