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NCT Number: NCT07182240

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LC-OCT Imaging

Device

handheld imaging device will take high resolution images of lesion

Primary outcomes

  1. Number of cases with fully evaluable images

    Time frame: 1.5 years

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

Secondary outcomes

  1. Patient interest in study

    Time frame: 1.5 years

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

  2. Patients overall experience

    Time frame: one office visit - immediately after imaging procedure

    Collect a 3-question questionnaire to document patients experience.

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

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

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

  4. Accuracy of LC-OCT findings

    Time frame: 1.5 years

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

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

    Time frame: 1.5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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