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

Launched by JACEK CALIK · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for Basal Cell Carcinoma (BCC), which is the most common type of skin cancer. The treatment uses high-intensity focused ultrasound (HIFU), a technique that targets cancer cells without harming the surrounding skin. The goal is to see how safe and effective this treatment is three months after a quick, single session. Participants will have follow-up visits every three months for a year to monitor their progress.

To join the study, participants must be 18 years or older and have been diagnosed with BCC that is no thicker than 2.0 mm. They should be able to understand and follow the treatment instructions and be comfortable with having photos of their condition taken for research purposes. However, individuals who are pregnant, have advanced skin cancer, or certain health conditions that could complicate treatment are not eligible. This trial is currently recruiting participants and aims to offer a promising new option for treating BCC, especially as rates of this cancer continue to rise.

Gender

ALL

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