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

NCT ID: NCT07182240

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-04-01

Brief Summary

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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

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Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

LC-OCT imaging

Group Type OTHER

LC-OCT Imaging

Intervention Type DEVICE

handheld imaging device will take high resolution images of lesion

Interventions

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LC-OCT Imaging

handheld imaging device will take high resolution images of lesion

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gyorgy Paragh, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park

Locations

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Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ask RPCI

Role: CONTACT

Phone: 1-800-767-9355

Email: [email protected]

Other Identifiers

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I-3839125

Identifier Type: -

Identifier Source: org_study_id