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Recruiting NCT07182240

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

No phase Interventional Basal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LC-OCT Imaging.
Who it may be relevant to
Registry conditions: Basal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Device LC-OCT Imaging
    handheld imaging device will take high resolution images of lesion

Primary outcome measures

  • Number of cases with fully evaluable images [Time frame: 1.5 years]
Secondary outcome measures (5)
  • Patient interest in study [Time frame: 1.5 years]
  • Patients overall experience [Time frame: one office visit - immediately after imaging procedure]
  • Determine LC-OCT imaging's impact on surgical workflow [Time frame: To be filled out immediately after finishing Mohs procedure]
  • Accuracy of LC-OCT findings [Time frame: 1.5 years]
  • Accuracy of LC-OCT in detectng location of tumor [Time frame: 1.5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Roswell Park Comprehensive Cancer Center — Buffalo

Identifiers

NCT: NCT07182240 · I-3839125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗