Using line-field confocal OCT to map Mohs surgery margins for basal cell carcinoma
Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas
NA · Roswell Park Cancer Institute · NCT07182240
This tests whether line-field confocal optical coherence tomography (LC-OCT) can noninvasively show the edges of basal cell carcinomas in adults scheduled for Mohs surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute (other) |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07182240 on ClinicalTrials.gov |
What this trial studies
This single-center pilot will use LC-OCT imaging on patients with superficial or mixed-feature basal cell carcinomas who are clinically eligible for Mohs micrographic surgery. Imaging will be performed before surgery using a mineral oil optical interface to capture high-resolution images of tumor margins. Results will be compared with the surgical margin findings from Mohs excision to determine feasibility and potential concordance. The study excludes patients with mineral oil allergy or uncontrolled illnesses that would limit participation.
Who should consider this trial
Good fit: Adults aged 18 or older with a basal cell carcinoma that has superficial histology (or mixed features including superficial) and who are planned for Mohs surgery are ideal candidates.
Not a fit: Patients with non-superficial BCC subtypes, known allergy to the mineral oil used for imaging, or uncontrolled medical/psychiatric conditions are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, LC-OCT could help surgeons better define tumor borders before Mohs, potentially reducing the amount of healthy tissue removed and shortening procedure time.
How similar studies have performed: Related noninvasive techniques like reflectance confocal microscopy and conventional OCT have shown promise for margin detection, but LC-OCT is a newer modality with limited pilot data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Gyorgy Paragh, MD — Roswell Park
- Study coordinator: Ask RPCI
- Email: askrpc@Roswellpark.org
- Phone: 1-800-767-9355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Basal Cell Carcinoma