Raman Spectroscopy and Skin Cancer

NCT06384924 | Recruiting FDA Device

• 1 other identifier: SBU-RAMAN-SKINCANCER
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

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

  1 year

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

  1 year

Study Arms (1)

Raman Spectroscopy

Device: Raman Spectroscopy handheld probe (EmVision, FL, USA); Device: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)

Interventions

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

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.

Raman Spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will include patients with confirmed skin cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tiezhi Zhang: lead

Study Sites (1)

Stony Brook Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Tiezhi Zhang

  Stony Brook Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiezhi Zhang

CONTACT

631-444-3617; tiezhi.zhang@stonybrookmedicine.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Physicist, Clinical Assistant Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): February 13, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)