Basal Cell Carcinoma
Conditions
Brief 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).
Interventions
DEVICELC-OCT Imaging
handheld imaging device will take high resolution images of lesion
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases with fully evaluable images | 1.5 years | cases were the image evaluator can assess the margins based on image quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient interest in study | 1.5 years | Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study |
| Patients overall experience | one office visit - immediately after imaging procedure | Collect a 3-question questionnaire to document patients experience. |
| Determine LC-OCT imaging's impact on surgical workflow | To be filled out immediately after finishing Mohs procedure | Will be assessed by results of imaging assessment questionnaire given to surgeon |
| Accuracy of LC-OCT findings | 1.5 years | Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results |
| Accuracy of LC-OCT in detectng location of tumor | 1.5 years | will be evaluated by comparing the location of the LC-OCT reported margin positivity to the Mohs map |
Countries
United States
Contacts
CONTACTAsk RPCI
PRINCIPAL_INVESTIGATORGyorgy Paragh, MD
Roswell Park
Outcome results
None listed