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

Last updated: January 31, 2023
Sponsor: Jacek Calik
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Basal Cell Carcinoma

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05698706
HIFU-BCC-2023-1
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Subjects of each gender aged 18 years or older at the time of informed consent. Thereis no upper limit of age.
  • Subjects who have received oral and written study information, accepted participationand signed the informed consent document.
  • Subjects who are willing and mentally and physically capable to understand and followthe treatment and follow-up schedule including post-treatment care instructions.
  • Subjects who are willing to have photographs and images taken of the treated lesionsto be used anonymously or coded in evaluations and publications.
  • Subjects, who have histologically and clinically verified basal cell carcinoma cancerof thickness not more 2.0 mm measured by ultrasound imaging or histopathologicalexamination.

Exclusion

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 usesuch as radiotherapy or Mohs' surgery has priority and offers the patient betteropportunity of cure.
  • Cancers on anatomical sites where the ultrasound probe cannot be adapted foranatomical reasons
  • Any systemic disease that according to investigator's assessment may interfere withthe spontaneous course of a skin cancer.
  • Any condition predisposing to treatment-related adverse effects or complications fromthe 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 theinvestigator, could interfere with the conduct of the study
  • Subjects undergoing immunosuppressive treatment

Study Design

Total Participants: 27
Study Start date:
December 14, 2022
Estimated Completion Date:
May 14, 2025

Connect with a study center

  • Old Town Clinic

    Wrocław, 50-127
    Poland

    Active - Recruiting

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