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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • LC-OCT Imaging

    Device

    handheld imaging device will take high resolution images of lesion

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)Other 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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