Two Photon Microscopy for Skin Cancer

Overseen By Michael G Giacomelli, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During Mohs surgery

92 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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. ^{1 3 5 6 7}

Who Is on the Research Team?

Michael G Giacomelli, Ph.D

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: TPFM imaging of surgical margins Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Rochester Dermatologic Surgery

Collaborator

Trials

2

Recruited

140+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative evaluation of healthy epidermis by means of multiphoton microscopy and fluorescence lifetime imaging microscopy. Benati, E., Bellini, V., Borsari, S., et al.[2018]

Two-photon fluorescence microscopy (TPFM) can provide rapid, point-of-care diagnoses of nonmelanoma skin cancers (NMSCs) within minutes, showing similar histological features to conventional histology based on a study of 29 biopsy specimens.

TPFM demonstrated high diagnostic performance with 100% sensitivity and specificity for basal cell carcinoma, and overall 93% sensitivity and 100% specificity for NMSC, indicating its potential as an effective alternative to traditional biopsy analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. Ching-Roa, VD., Huang, CZ., Ibrahim, SF., et al.[2023]

Two-photon microscopy (TPM) techniques, including two-photon excitation fluorescence microscopy and second harmonic generation microscopy, are increasingly being used in cancer research to study human tissue pathology both ex vivo and in vivo.

These advanced imaging methods have the potential to significantly enhance the translation of cancer research into clinical practice, paving the way for minimally invasive diagnostic and therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-photon and second harmonic microscopy in clinical and translational cancer research. Perry, SW., Burke, RM., Brown, EB.[2021]

Multiphoton imaging of skin biopsies using specific irradiation regimes causes skin damage similar to that of everyday UV exposure, indicating a potential risk for skin health.

The study quantitatively assessed the effects of multiphoton irradiation compared to UV irradiation by measuring cyclobutane-pyrimidine dimers (CPDs), providing a basis for risk assessment in skin imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the risk of skin damage due to femtosecond laser irradiation. Fischer, F., Volkmer, B., Puschmann, S., et al.[2014]

Intravital two-photon microscopy is a cutting-edge imaging technology that allows researchers to observe live tissues in real-time with high resolution and minimal damage, making it superior to traditional methods like confocal microscopy.

This technique has significantly advanced our understanding of skin biology, including its immune responses and tumor development, by enabling detailed visualization of skin layers in both healthy and diseased states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Techniques Made Simple: Two-Photon Intravital Imaging of the Skin. Obeidy, P., Tong, PL., Weninger, W.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Review: Clinical in vivo multiphoton FLIM tomography. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Two-photon laser-scanning fluorescence microscopy applied for studies of human skin. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Quantitative evaluation of healthy epidermis by means of multiphoton microscopy and fluorescence lifetime imaging microscopy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Two-photon and second harmonic microscopy in clinical and translational cancer research. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Assessing the risk of skin damage due to femtosecond laser irradiation. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Research Techniques Made Simple: Two-Photon Intravital Imaging of the Skin. [2019]