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

Roswell Park Comprehensive Cancer Center

Status

Enrolling

Conditions

Basal Cell Carcinoma

Treatments

Device: LC-OCT Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT07182240

I-3839125

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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