Optical Coherence Tomography Guided C&D

NCT04510727 | Withdrawn FDA Device

• 1 other identifier: 20200212
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Basal Cell Carcinoma

Keywords

Superficial basal cell carcinoma; Nodular basal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

OCT Guided C&D Group

EXPERIMENTAL

Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D.

Device: Optical Coherence Tomography (OCT); Procedure: Curettage & Desiccation (C&D) Procedure

Interventions

Optical Coherence Tomography (OCT) DEVICE

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

OCT Guided C&D Group

Curettage & Desiccation (C&D) Procedure 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.

OCT Guided C&D Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Maria V Muniz

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Tomography, Optical Coherence; Curettage; Desiccation; Dilatation and Curettage

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Surgical Procedures, Operative; Chemistry Techniques, Analytical; Chemical Phenomena; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Keyvan Nouri, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: April 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)