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NCT Number: NCT06384924

Raman Spectroscopy and Skin Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stony Brook Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Renee Cattell, PhD

CONTACT

[email protected]

Renee Cattell, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Raman Spectroscopy handheld probe (EmVision, FL, USA)

Device

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.

Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)

Device

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

Primary outcomes

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

    Time frame: 1 year

    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.

Secondary outcomes

  1. Compare the size of clinically defined margin and Raman-defined margin

    Time frame: 1 year

    After generating a sufficient model for predicting cancerous from non-cancerous tissue based on Raman spectra, compare the volume of the clinically defined margin (uniform 1-2 centimeter margin upon clinical discretion) to the Raman-defined margin. The Raman-defined margin will not be used for treatment. The volume is measured in cc (cubic centimeter).

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

    Time frame: 1 year

    Radiation dose to the critical structures (e.g., eyes) from the plan using clinically defined margin (uniform 1-2 centimeter margin upon clinical discretion) will be collected. A second plan (not to be used for treatment) will be generated based on the Raman-defined margin. The dose to critical structures will be compared for both plans. The unit for dose will be centiGray (cGy).

Study contacts

Contact information is provided by the study sponsor or research team.

Tiezhi Zhang

CONTACT

[email protected]

631-444-3617

Sponsors and collaborators

Lead sponsor

Tiezhi Zhang

Other

Registry information

Official study title

Pilot Study of Raman Spectroscopic Imaging for Skin Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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