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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 Mohs surgery. The main question it aims to answer is:
• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
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 frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPFM imaging of surgical margins | Experimental | Patients will be imaged with TPFM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two photon microscopy imaging | Device | Excised tissues will be imaged with two photon microscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins | Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard | During Mohs surgery, typically less than 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts | Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael G Giacomelli, Ph.D | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Dermatologic Surgery | 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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Withdrawal group was due to technical issues during frozen sectioning or specimen holder failure. The first 10 patients of the study (pre-study training) were used to develop procedures and train readers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Two-photon Fluorescence Microscopy (TPFM) Imaging of Surgical Margins | Patients will be imaged with two-photon fluorescence microscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No difference
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| ID | Title | Description |
|---|---|---|
| BG000 | Two-photon Fluorescence Microscopy Imaging of Surgical Margins | Patients will be imaged with two-photon fluorescence microscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins | Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard | Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions. | Posted | Mean | 95% Confidence Interval | Percentage | During Mohs surgery, typically less than 60 minutes | Mohs micrographic surgery excisions | Mohs micrographic surgery excisions |
|
Duration of the surgery, typically less than 60 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Two-photon Fluorescence Microscopy Imaging of Surgical Margins | Patients will be imaged with two-photon fluorescence microscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Giacomelli | University of Rochester | 5852766260 | mgiacome@ur.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2025 | Jan 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2025 | Jan 13, 2026 | ICF_001.pdf |
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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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| During Mohs surgery, typically less than 60 minutes |
| Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis | Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections. | During Mohs surgery, typically less than 60 minutes |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Mohs micrographic surgery excisions |
|
|
| Secondary | Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts | Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section. | Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions. | Posted | Mean | 95% Confidence Interval | Percentage | During Mohs surgery, typically less than 60 minutes | Mohs micrographic surgery excisions | Mohs micrographic surgery excisions |
|
|
|
|
| Secondary | Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis | Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections. | Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions. | Posted | Mean | 95% Confidence Interval | Percentage | During Mohs surgery, typically less than 60 minutes | Mohs micrographic surgery excisions | Mohs micrographic surgery excisions |
|
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 0 |
| 135 |
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| D018295 |
| Neoplasms, Basal Cell |