92 Participants NeededMy employer runs this trial

Two-Photon Microscopy for Skin Cancer

MG
Overseen ByMichael Giacomelli, Ph.D
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for examining skin cancer biopsies using two-photon microscopy imaging. The goal is to determine if this technique, combined with a machine learning model, can match the results of traditional lab tests. It could make diagnosing skin cancer faster and more accurate in the clinic. Individuals with punch, excisional, or shave biopsy specimens are suitable participants, provided their biopsy is not for melanoma or similar conditions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform skin cancer diagnosis.

What prior data suggests that two-photon microscopy imaging is safe for evaluating dermatologic biopsies?

Research has shown that two-photon fluorescence microscopy (TPFM) on human skin is generally safe. In one study, more than 70% of skin cells remained healthy with this imaging method. Clinical studies also showed only slight redness and minimal cell damage, indicating that the treatment does not significantly harm skin cells. Safety is crucial when using this technology on human skin, and these studies suggest that TPFM is well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about two-photon microscopy (TPFM) for skin cancer because it offers a non-invasive way to diagnose the disease. Unlike traditional options that often require surgical biopsies, TPFM uses advanced imaging technology to visualize skin tissues at the cellular level. This method could reduce the need for invasive procedures and provide quicker, more accurate diagnoses, enhancing patient comfort and care. Additionally, by integrating machine learning for analysis, TPFM has the potential to improve diagnostic precision, making it a promising tool for early detection and treatment planning.

What evidence suggests that two-photon microscopy is effective for evaluating skin cancer?

This trial will evaluate the effectiveness of two-photon fluorescence microscopy (TPFM) for diagnosing skin cancers. Studies have shown that TPFM can be highly effective. One study found that it identified squamous cell carcinoma with 89% sensitivity and 100% specificity. Another study demonstrated that TPFM diagnosed basal cell carcinoma with perfect accuracy, or 100%. These findings suggest that TPFM could enable doctors to make quick and accurate diagnoses. In this trial, TPFM will image specimens, and a machine learning model will diagnose them, potentially providing a reliable alternative to traditional biopsy methods for identifying nonmelanoma skin cancers.14678

Are You a Good Fit for This Trial?

This trial is for people who are having a skin biopsy to check for types of skin cancer like basal cell carcinoma or squamous cell carcinoma. There are no detailed inclusion or exclusion criteria listed.

Inclusion Criteria

I have had a punch, excisional, or shave biopsy.

Exclusion Criteria

My biopsy is for melanoma or an atypical mole.
My tumor removal was less than 2 mm in its longest size.
My tumor was removed and was less than 1 mm thick.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Diagnosis

Biopsy specimens are imaged using two-photon fluorescence microscopy and evaluated by a machine learning model for diagnosis

Same day as biopsy
1 visit (in-person)

Histological Processing and Comparison

Specimens undergo histological processing for comparison with machine learning model diagnosis

1-2 weeks

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 tests if a machine learning model can accurately analyze two-photon fluorescence microscopy images of skin biopsies, comparing its results to standard lab analysis (histology).

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TPFM imaging of biopsyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Rochester Dermatologic Surgery

Collaborator

Trials
2
Recruited
140+

Citations

Real-time Analysis of Skin Biopsy Specimens With 2- ...

The study results suggest that 2-photon fluorescence microscopy may facilitate real-time diagnosis of nonmelanoma skin cancers and other ...

Real-time Analysis of Skin Biopsy Specimens With 2-Photon ...

The study results suggest that 2-photon fluorescence microscopy may facilitate real-time diagnosis of nonmelanoma skin cancers and other ...

Two-photon fluorescence microscopy may help diagnose ...

For the squamous cell carcinoma samples, the novel approach yielded an 89% sensitivity (95% CI, 52%-100%), 100% specificity (95% CI, 54%-100%) ...

Two Photon Microscopy for Skin Cancer · Info for Participants

Research has shown that using two-photon fluorescence microscopy on human skin is safe. In one study, over 70% of skin cells remained healthy even at the ...

Two-Photon Microscopy and Diagnostic Applications

it produces very high speed and high resolution results. these study results showed positive patients had varied fluorescent activity in skin ...

Live imaging of skin immunity using two-photon microscopy

Technical and safety considerations. When intravital imaging is applied to human skin, safety considerations are of paramount importance.

Two-Photon Intravital Imaging of the Skin

there are limited human safety data for multiphoton imaging in the skin, clinical studies indicate minimal erythema and cellular damage from ...

Real-time Analysis of Skin Biopsy Specimens With 2- ...

Two-photon fluorescence microscopy (TPFM) has the potential for point-of-care diagnosis of NMSC and other dermatologic conditions, which could ...