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

January 16, 2023 updated by: Jacek Calik

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bartosz Wozniak, MD
  • Phone Number: +48 516 222 516

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: 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
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
Selected BCC sites will be treated using high intensity focused ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate
Time Frame: 3 months
Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no
3 months
Severity of short term adverse events
Time Frame: 3 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Frequency of complete clearance of BCC after HIFU treatment measured at 6, 9, 12 months after HIFU treatment. Binary output: yes/no
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacek Calik

Investigators

  • Principal Investigator: Jacek Calik, MD, PhD, Old Town Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Anticipated)

May 14, 2025

Study Completion (Anticipated)

May 14, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU-BCC-2023-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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