Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
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: Two photon fluorescence microscopy imaging.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma. Basic parameters: No limits · 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 →
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Overview
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
- Device Two photon fluorescence microscopy imaging
Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.
Primary outcome measures
- Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology [Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery]
Secondary outcome measures (1)
- Overall agreement on margin status [Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery]
Eligibility criteria
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
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
- Rochester Dermatologic Surgery — Victor
Publications
- Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628. PMID 36069886
Identifiers
NCT: NCT06473103 · STUDY00009521