We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05698706
Recruitment Status : Recruiting
First Posted : January 26, 2023
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Jacek Calik, Old Town Clinic, Poland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Device: TOOsonix System ONE-M Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety
Actual Study Start Date : December 14, 2022
Estimated Primary Completion Date : May 14, 2025
Estimated Study Completion Date : May 14, 2025
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cure rate [ Time Frame: 3 months ]
    Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no

  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05698706


Contacts
Layout table for location contacts
Contact: Jacek Calik, MD, PhD +48 516 222 516 jacek.calik@oldtownclinic.pl
Contact: Bartosz Wozniak, MD +48 516 222 516

Locations
Layout table for location information
Poland
Old Town Clinic Recruiting
Wrocław, Poland, 50-127
Contact: Jacek Calik, MD, PhD    +48 516 222 516    jacek.calik@oldtownclinic.pl   
Sponsors and Collaborators
Jacek Calik
Investigators
Layout table for investigator information
Principal Investigator: Jacek Calik, MD, PhD Old Town Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Jacek Calik, Managing Director, Old Town Clinic, Poland
ClinicalTrials.gov Identifier: NCT05698706    
Other Study ID Numbers: HIFU-BCC-2023-1
First Posted: January 26, 2023    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacek Calik, Old Town Clinic, Poland:
Skin cancer
HIFU
BCC
 Dermatology
High Intensity Focused Ultrasound
Dermoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell