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| Name | Class |
|---|---|
| Rochester Dermatologic Surgery | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPFM imaging of surgical margins | Experimental | Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two photon fluorescence microscopy imaging | Device | Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology | 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. | Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall agreement on margin status | The status of margins (positive/negative) will be compared | Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Giacomelli, Ph.D. | Contact | 5852766260 | mgiacome@ur.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Giacomelli | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Dermatologic Surgery | Recruiting | Victor | New York | 14654 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36069886 | Background | 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. |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D018295 |
| Neoplasms, Basal Cell |