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Clinical Trials/NCT04510727
NCT04510727WithdrawnNot Applicable

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

University of Miami2 sites in 1 countryStarted: April 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Keyvan Nouri

Professor

University of Miami

Study Sites (2)

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