NCT04510727WithdrawnNot Applicable
Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Locations
- 2
- Primary Endpoint
- The incidence of residual basal cell carcinoma tumor cells
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The incidence of residual basal cell carcinoma tumor cells
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Keyvan Nouri
Professor
University of Miami
Study Sites (2)
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