HIFU for Treatment of Non-nodular and Recurrent BCC

Launched by JOERGEN SERUP · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment method for basal cell carcinoma (BCC), which is the most common type of skin cancer. The study is focused on using a special device that utilizes high-intensity focused ultrasound to target and destroy small areas of BCC cells without harming the surrounding skin. The goal is to see how safe and effective this treatment is after just one short session lasting 3 to 5 minutes, with follow-up evaluations over the next year to monitor results.

To be eligible for this trial, participants should be at least 18 years old and have been diagnosed with either newly identified non-nodular BCC or recurrent BCC that has been treated before. Those interested must be able to understand and follow treatment instructions and agree to have photos taken of their skin for research purposes. It’s important to note that this trial is not for individuals with certain health issues or more advanced skin cancers that might require different treatments. If you join the study, you can expect close monitoring and support from the research team throughout the year.

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 either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included.
• 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 the basal cell carcinoma under study located nearby (\<5 cm) an implant or a site injected with a dermal filler or paraffin.
• • Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.