Raman Spectroscopy and Skin Cancer

Recruiting

• Conditions: Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma
• Interventions: Device: Raman Spectroscopy handheld probe (EmVision, FL, USA); Device: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)

• Registration Number: NCT06384924
• Lead Sponsor: Renee Farrell

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Study Start: 2025-02-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-02-13
• Study Completion: 2027-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Raman Spectroscopy	Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)	-
Raman Spectroscopy	Raman Spectroscopy handheld probe (EmVision, FL, USA)	-

Primary Outcome Measures

Name	Time	Method
Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.	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 Outcome Measures

Name	Time	Method
Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin	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).
Compare the size of clinically defined margin and Raman-defined margin	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).

Trial Locations

Locations (1)

Stony Brook Hospital; 🇺🇸 Stony Brook, New York, United States