Two Photon Microscopy for Skin Cancer
Recruiting in Palo Alto (17 mi)
Overseen byMichael G Giacomelli, Ph.D
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12567How 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.
12357Eligibility 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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Rochester Dermatologic SurgeryVictor, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
Rochester Dermatologic SurgeryCollaborator
References
Review: Clinical in vivo multiphoton FLIM tomography. [2021]Fluorescence Lifetime Imaging (FLIM) in life sciences based on ultrashort laser scanning microscopy and time-correlated single photon counting (TCSPC) started 30 years ago in Jena/East-Germany. One decade later, first two-photon FLIM images of a human finger were taken with a lab microscope based on a tunable femtosecond Ti:sapphire laser. In 2002/2003, first clinical non-invasive two-photon FLIM studies on patients with dermatological disorders were performed using a novel multiphoton tomograph. Current in vivo two-photon FLIM studies on human subjects are based on TCSPC and focus on (i) patients with skin inflammation and skin cancer as well as brain tumors, (ii) cosmetic research on volunteers to evaluate anti-ageing cremes, (iii) pharmaceutical research on volunteers to gain information on in situ pharmacokinetics, and (iv) space medicine to study non-invasively skin modifications on astronauts during long-term space flights. Two-photon FLIM studies on volunteers and patients are performed with multiphoton FLIM tomographs using near infrared femtosecond laser technology that provide rapid non-invasive and label-free intratissue autofluorescence biopsies with picosecond temporal resolution.
Two-photon laser-scanning fluorescence microscopy applied for studies of human skin. [2009]Two-photon laser scanning fluorescence microscopy (TPM) has been shown to be advantageous for imaging optically turbid media such as human skin. The ability of performing three-dimensional imaging without presectioning of the samples makes the technique not only suitable for noninvasive diagnostics but also for studies of topical delivery of xenobiotics. Here, TPM is used as a method to visualize both autofluorescent and exogenous fluorophores in skin. Samples exposed to sulforhodamine B have been scanned from two directions to investigate attenuation effects. It is shown that optical effects play a major role. Thus, TPM is excellent for visualizing the localization and distribution of fluorophores in human skin, although quantification might be difficult. Furthermore, an image-analysis algorithm has been implemented to facilitate interpretation of TPM images of autofluorescent features of nonmelanoma skin cancer obtained ex vivo. The algorithm was designed to detect cell nuclei and currently has a sensitivity and specificity of 82% and 78% to single cell nuclei. However, in order to detect multinucleated cells, the algorithm needs further development.
Quantitative evaluation of healthy epidermis by means of multiphoton microscopy and fluorescence lifetime imaging microscopy. [2018]Multiphoton microscopy (MPM) enables the assessment of unstained living biological tissue with submicron resolution, whereas fluorescence lifetime imaging microscopy (FLIM) generates image contrast between different states of tissue characterized by various fluorescence decay rates. The aim of this study was to compare the healthy skin of young individuals with that of older subjects, as well as to assess the skin at different body sites, by means of MPM and FLIM.
Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. [2023]Nonmelanoma skin cancers (NMSCs) are primarily diagnosed through paraffin section histologic analysis of skin biopsy specimens that requires days to weeks before a formal diagnosis is reported. Two-photon fluorescence microscopy (TPFM) has the potential for point-of-care diagnosis of NMSC and other dermatologic conditions, which could enable same-visit diagnosis and treatment.
Two-photon and second harmonic microscopy in clinical and translational cancer research. [2021]Application of two-photon microscopy (TPM) to translational and clinical cancer research has burgeoned over the last several years, as several avenues of pre-clinical research have come to fruition. In this review, we focus on two forms of TPM-two-photon excitation fluorescence microscopy, and second harmonic generation microscopy-as they have been used for investigating cancer pathology in ex vivo and in vivo human tissue. We begin with discussion of two-photon theory and instrumentation particularly as applicable to cancer research, followed by an overview of some of the relevant cancer research literature in areas that include two-photon imaging of human tissue biopsies, human skin in vivo, and the rapidly developing technology of two-photon microendoscopy. We believe these and other evolving two-photon methodologies will continue to help translate cancer research from the bench to the bedside, and ultimately bring minimally invasive methods for cancer diagnosis and treatment to therapeutic reality.
Assessing the risk of skin damage due to femtosecond laser irradiation. [2014]We irradiated freshly excised skin biopsies with four irradiation regimes usually taken for multiphoton imaging. If there is any skin damaging, it is mainly an effect similar to the damaging effects of UV-irradiation. Using fluorescent antibodies against cyclobutane-pyrimidin-dimers (CPDs) in combination with immuno-fluorescence image analysis we quantitatively compared fs-irradiation effects with UV-irradiation (solar simulator). Based on these results we are giving a risk assessment. The results show that multi photon imaging using the parameters described here is in the ballpark of damaging occurring from every day sun exposure.
Research Techniques Made Simple: Two-Photon Intravital Imaging of the Skin. [2019]Over the last few years, intravital two-photon microscopy has matured into a powerful technology helping basic and clinical researchers obtain quantifiable details of complex biological mechanisms in live and intact tissues. Two-photon microscopy provides high spatial and temporal resolution in vivo with little phototoxicity that is unattainable by other optical tools like confocal microscopy. Using ultrashort laser pulses, two-photon microscopy allows the visualization of molecules, cells, and extracellular structures up to depths of 1 mm within tissues. Consequently, real-time imaging of the individual skin layers under both physiological and pathological conditions has revolutionized our understanding of cutaneous homeostasis, immunity, and tumor biology. This review provides an overview to two-photon microscopy of the skin by covering the basic concepts and current applications in diverse preclinical and clinical settings.