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

Not Applicable

Not yet recruiting

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT07182240
• Lead Sponsor: Roswell Park Cancer Institute

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of cases with fully evaluable images	1.5 years	cases were the image evaluator can assess the margins based on image quality

Secondary Outcome Measures

Name	Time	Method
Patient interest in study	1.5 years	Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study
Patients overall experience	one office visit - immediately after imaging procedure	Collect a 3-question questionnaire to document patients experience.
Determine LC-OCT imaging's impact on surgical workflow	To be filled out immediately after finishing Mohs procedure	Will be assessed by results of imaging assessment questionnaire given to surgeon
Accuracy of LC-OCT findings	1.5 years	Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results
Accuracy of LC-OCT in detectng location of tumor	1.5 years	will be evaluated by comparing the location of the LC-OCT reported margin positivity to the Mohs map

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States