92 Participants Needed

Two Photon Microscopy for Skin Cancer

MG
Overseen ByMichael G Giacomelli, Ph.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Two-photon microscopy imaging for skin cancer?

Research shows that two-photon microscopy can help visualize skin cancer by providing detailed images of skin tissue without needing to cut it. This method has been used successfully in studies to diagnose skin conditions quickly and non-invasively, which could lead to faster treatment decisions.12345

Is two-photon microscopy safe for use in humans?

Two-photon microscopy is generally considered safe for use in humans, with studies indicating that any potential skin damage is similar to everyday sun exposure. It provides high-resolution imaging with minimal phototoxicity (light-induced damage) compared to other methods.12567

How is two-photon microscopy imaging different from other skin cancer treatments?

Two-photon microscopy imaging is unique because it allows for high-resolution, real-time imaging of skin layers without needing to cut the skin, using ultrashort laser pulses to visualize cells and structures up to 1 mm deep. This non-invasive method provides detailed insights into skin cancer and other conditions, unlike traditional methods that may require tissue samples.12357

What is the purpose of this trial?

This trial aims to see if a special imaging technique called TPFM can help doctors find any remaining cancer cells during skin cancer surgery. It focuses on patients with basal cell carcinoma and compares TPFM results with other methods to ensure accuracy.

Research Team

MG

Michael G Giacomelli, Ph.D

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for individuals who can read and understand a consent form and are currently undergoing Mohs surgery for basal cell carcinoma (BCC) at the location where the study is being conducted.

Inclusion Criteria

Able to read and understand consent form
I am receiving Mohs surgery for basal cell carcinoma at the study site.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Mohs surgery with TPFM imaging of surgical margins followed by standard of care frozen section analysis

During Mohs surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Two photon microscopy imaging
Trial Overview The study is testing two photon fluorescence microscopy to see if it's as good as the standard frozen section histology in identifying cancerous tissue during Mohs surgery for BCC.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TPFM imaging of surgical marginsExperimental Treatment1 Intervention
Patients will be imaged with TPFM

Two photon microscopy imaging is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Two-photon fluorescence microscopy for:
  • Diagnostic tool for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma
🇪🇺
Approved in European Union as Two-photon fluorescence microscopy for:
  • Research and diagnostic tool for skin cancers, including basal cell carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Rochester Dermatologic Surgery

Collaborator

Trials
2
Recruited
140+

Findings from Research

Two-photon fluorescence lifetime imaging (FLIM) is a non-invasive technique that has been successfully used in clinical studies to assess skin inflammation, skin cancer, and brain tumors, providing rapid and detailed insights into tissue health.
This advanced imaging method also has applications in cosmetic research and space medicine, allowing researchers to evaluate the effectiveness of anti-aging products and study skin changes in astronauts during long-term space missions.
Review: Clinical in vivo multiphoton FLIM tomography.König, K.[2021]
Two-photon laser scanning fluorescence microscopy (TPM) is effective for noninvasive imaging of human skin, allowing for three-dimensional visualization of both natural and introduced fluorescent markers, which is useful for studying drug delivery and skin diagnostics.
An image-analysis algorithm developed for TPM images can accurately identify cell nuclei in nonmelanoma skin cancer samples with a sensitivity of 82% and specificity of 78%, although it requires further refinement to detect multinucleated cells.
Two-photon laser-scanning fluorescence microscopy applied for studies of human skin.Ericson, MB., Simonsson, C., Guldbrand, S., et al.[2009]
The study used multiphoton microscopy (MPM) and fluorescence lifetime imaging microscopy (FLIM) to analyze skin differences between 30 young individuals and 19 elderly patients, revealing significant morphological changes in the skin of older adults.
Elderly subjects exhibited smaller cell and nucleus sizes, decreased basal cell numbers, and increased fluorescence lifetimes, indicating age-related alterations in skin structure that could help clinicians differentiate between healthy and diseased skin states.
Quantitative evaluation of healthy epidermis by means of multiphoton microscopy and fluorescence lifetime imaging microscopy.Benati, E., Bellini, V., Borsari, S., et al.[2018]

References

Review: Clinical in vivo multiphoton FLIM tomography. [2021]
Two-photon laser-scanning fluorescence microscopy applied for studies of human skin. [2009]
Quantitative evaluation of healthy epidermis by means of multiphoton microscopy and fluorescence lifetime imaging microscopy. [2018]
Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. [2023]
Two-photon and second harmonic microscopy in clinical and translational cancer research. [2021]
Assessing the risk of skin damage due to femtosecond laser irradiation. [2014]
Research Techniques Made Simple: Two-Photon Intravital Imaging of the Skin. [2019]
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