Basal Cell Carcinoma
Conditions
Brief summary
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.
Detailed description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.
Interventions
DEVICETwo photon fluorescence microscopy imaging
Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.
Sponsors
Rochester Dermatologic Surgery
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site * Able to read and understand consent form
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology | Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery | The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall agreement on margin status | Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery | The status of margins (positive/negative) will be compared |
Countries
United States
Contacts
Primary ContactMichael Giacomelli, Ph.D.
Outcome results
None listed