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Optical Coherence Tomography Guided C&D

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04510727
Enrollment
0
Registered
2020-08-12
Start date
2024-04-01
Completion date
2025-02-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

Superficial basal cell carcinoma, Nodular basal cell carcinoma

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).

Interventions

DEVICEOptical Coherence Tomography (OCT)

VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.

PROCEDURECurettage & 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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of residual basal cell carcinoma tumor cells2 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026