Investigation of the Vivosight system for diagnosis and assistance in the management of cutaneous basal cell carcinoma (BCC)
Not Applicable
Completed
- Conditions
- Cutaneous basal cell carcinomaCancer - Non melanoma skin cancer
- Registration Number
- ACTRN12614000751673
- Lead Sponsor
- Melanoma Institute of Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
Patients must be aged 18 years or older; present with pink patch lesions that are suspected superficial basal cell carcinomas; be able to follow trial instructions; and be likely to complete all trial requirements (must be willing to give written informed consent and to allow photographs and images of the selected treatment area).
Exclusion Criteria
Patients unable to give consent or follow trial instructions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmation that optical coherence tomography (OCT) can diagnose superficial BCC with >95% sensitivity and >75% specificity. This will be done by measuring the frequencies of the OCT features in different BCC cases. Significant differences between superficial BCC and other types of BCCs will be evaluated by means of Chi square test of independence. Multivariate analysis and binary logistic regression will be performed for the identification of the independently significant features and for the validation of the efficacy of OCT in distinguishing between superficial BCC and other types of BCC.[Primary timepoint will be assessed at recruitment or baseline visit.]
- Secondary Outcome Measures
Name Time Method Quantification of how well OCT measures the depth of superficial lesions compared to histology. This will be done by comparing the lesion depth on the OCT scan and the lesion depth on pathology based on the biopsy.[This will be assessed at recruitment or baseline visit.];Agreement between OCT and histology at day 1 and day 180 of follow-up for clearance / treatment failure.[Baseline and 180 day follow up]