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RecruitingNCT07182240Updated Sep 24, 2026

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

An interventional study of LC-OCT Imaging in Basal Cell Carcinoma, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Basal Cell Carcinoma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

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

    LC-OCT imaging

    Device: LC-OCT Imaging

Interventions

  • DeviceLC-OCT Imaging

    handheld imaging device will take high resolution images of lesion

05

What researchers measure

Primary outcomes

  1. Number of cases with fully evaluable images

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

    Time frame: 1.5 years

Secondary outcomes

  1. Patient interest in study

    Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study

    Time frame: 1.5 years

  2. Patients overall experience

    Collect a 3-question questionnaire to document patients experience.

    Time frame: one office visit - immediately after imaging procedure

  3. Determine LC-OCT imaging's impact on surgical workflow

    Will be assessed by results of imaging assessment questionnaire given to surgeon

    Time frame: To be filled out immediately after finishing Mohs procedure

  4. Accuracy of LC-OCT findings

    Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results

    Time frame: 1.5 years

  5. Accuracy of LC-OCT in detectng location of tumor

    will be evaluated by comparing the location of the LC-OCT reported margin positivity to the Mohs map

    Time frame: 1.5 years

06

Study locations

1 of 1 sites recruiting
  • Roswell Park Comprehensive Cancer Center
    Buffalo, New York 14263, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07182240
Lead sponsor
Roswell Park Cancer Institute
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Dec 22, 2025
Primary completion
Jun 22, 2027 (estimated)
Completion
Jun 22, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Ask RPCI
Contact
askrpc@Roswellpark.org
1-800-767-9355
Cerrene Giordano, MD
principal investigator · Roswell Park

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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