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RecruitingObservational

Pilot Study of Raman Spectroscopic Imaging for Skin Cancer

NCT ID: NCT06384924Sponsor: Tiezhi ZhangLast updated: 2026-05-07

Summary

The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is: -Can Raman Spectroscopy help figure out how far a tumor spreads? This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin.

Detailed description

Radiation therapy is an alternative to surgery for localized tumors with excellent tumor control and cosmetic outcome. Raman Spectroscopy has potential to be a useful non-invasive, non-destructive, real-time, in-vivo tool for differentiation of cancerous vs. non-cancerous tissues. With this knowledge and future studies, this will ultimately guide skin brachytherapy more accurately and avoid unnecessary radiation to cosmetically and functionally important tissues including eyelid, nose, lips or skin folds. The purpose of this study is to determine the feasibility of Raman Spectroscopy to identify microscopic infiltration extent of skin cancer beyond grossly visible tumor, using artificial intelligence methods of supervised and un-supervised machine learning algorithms, including pattern recognition, convolutional neural networks, k-means clustering and principal component analysis.

Arms & interventions

  • DeviceRaman Spectroscopy handheld probe (EmVision, FL, USA)

    The probe is approximately the size of a pen or pencil. The handheld probe is connected to the laser source using a cable. The probe is placed in light contact with the skin. The features of the laser light after it bounces off the skin is collected. This measurement can allow us to see tissue characteristics. This is a single session that will take approximately 15 minutes.

  • DeviceRaman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)

    This light source will create the laser light that will pass through the cable and through the handheld probe onto the skin.

Outcome measures

Primary

  • Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.

    Collect the Raman spectroscopy data starting from the center of visible lesion moving outward and also contralateral normal skin. Observe the different spectra peak wavelengths and intensities, which correspond to different chemical composition of the tissue. The Raman Spectra has units of wavelength Raman shift (1/centimeter) on the horizontal axis and arbitrary units of intensity on the vertical axis.

    Time frame: 1 year

Secondary

  • Compare the size of clinically defined margin and Raman-defined margin

    Time frame: 1 year

  • Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Histologically confirmed skin cancer (either basal cell carcinoma or squamous cell carcinoma) * Participants must plan to receive brachytherapy treatment for the skin cancer at the study site. * Ability to provide consent to the study. Exclusion Criteria: * Patient belongs to a vulnerable population (Minors (under 18 years old), Adults unable to consent, prisoners). * Lesions on the eyelid or in close proximity to the eye * Pregnant women, or women of childbearing age who refuse pregnancy testing. * Patient has pacemaker.

Study locations (1)

Stony Brook Hospital

Stony Brook, New York, 11794

Recruiting
Renee Cattell, PhD · Contact
Renee Cattell, PhD · Principal Investigator
Raman Spectroscopy and Skin Cancer | Cancerify