Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

NCT ID: NCT06473103

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TPFM imaging of surgical margins

Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.

Group Type EXPERIMENTAL

Two photon fluorescence microscopy imaging

Intervention Type DEVICE

Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Interventions

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Two photon fluorescence microscopy imaging

Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rochester Dermatologic Surgery

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Michael Giacomelli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Giacomelli

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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Rochester Dermatologic Surgery

Victor, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Giacomelli, Ph.D.

Role: CONTACT

5852766260

Facility Contacts

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Sherrif Ibrahim, MD-Ph.D.

Role: primary

585-222-1400

References

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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.

Reference Type BACKGROUND
PMID: 36069886 (View on PubMed)

Other Identifiers

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STUDY00009521

Identifier Type: -

Identifier Source: org_study_id

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