Optical Coherence Tomography Guided C&D
Not Applicable
Withdrawn
- Conditions
- Basal Cell Carcinoma
- Interventions
- Device: Optical Coherence Tomography (OCT)Procedure: Curettage & Desiccation (C&D) Procedure
- Registration Number
- NCT04510727
- Lead Sponsor
- University of Miami
- Brief Summary
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
- Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
- No prior treatment on the lesion within the last 3 months.
- Lesions anywhere except the head, neck and distal extremities.
- Willing and able to sign informed consent
Exclusion Criteria
- Aggressive BCC types.
- Recurrent tumors.
- Lesion treated within last 3 months.
- Lesions on head and neck (high risk areas)
- Lesions on distal extremities (thin epidermis not preferred for OCT).
- Pregnant women.
- Patients less than 18 years old.
- Prisoners.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCT Guided C&D Group Optical Coherence Tomography (OCT) Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D. OCT Guided C&D Group Curettage & Desiccation (C&D) Procedure Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D.
- Primary Outcome Measures
Name Time Method The incidence of residual basal cell carcinoma tumor cells 2 months (post C&D procedure) The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C\&D as assessed using the OCT.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maria V Muniz
🇺🇸Miami, Florida, United States