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NCT04510727 Clinical Trial

Optical Coherence Tomography Guided C&D

Basal Cell Carcinoma Clinical Trial

Official title:
Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04510727
Other study ID # 20200212
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date February 1, 2025

Study information
Verified date February 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Optical Coherence Tomography (OCT)
VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
Procedure:
• Curettage & Desiccation (C&D) Procedure
Standard of care C&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.

Locations
Country Name City State
United States Maria V Muniz Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of residual basal cell carcinoma tumor cells The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C&D as assessed using the OCT. 2 months (post C&D procedure)
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