Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas

NCT07182240 | Recruiting FDA Device

• 1 other identifier: I-3839125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of cases with fully evaluable images

  cases were the image evaluator can assess the margins based on image quality

  1.5 years

Secondary Outcomes (5)

• Patient interest in study

  1.5 years

• Patients overall experience

  one office visit - immediately after imaging procedure

• Determine LC-OCT imaging's impact on surgical workflow

  To be filled out immediately after finishing Mohs procedure

• Accuracy of LC-OCT findings

  1.5 years

• Accuracy of LC-OCT in detectng location of tumor

  1.5 years

Study Arms (1)

Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)

OTHER

LC-OCT imaging

Device: LC-OCT Imaging

Interventions

LC-OCT Imaging DEVICE

handheld imaging device will take high resolution images of lesion

Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.
• Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.
• The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.

You may not qualify if:

• Known or reported allergy to mineral oil, the optical agent used during imaging.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
• Unwilling or unable to follow protocol requirements

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Gyorgy Paragh, MD

  Roswell Park

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ask RPCI

CONTACT

1-800-767-9355; askrpc@Roswellpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)