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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

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)