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Recruiting NCT06384924

Raman Spectroscopy and Skin Cancer

— Observational Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Raman Spectroscopy handheld probe (EmVision, FL, USA), Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA).
Who it may be relevant to
Registry conditions: Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study of Raman Spectroscopic Imaging for Skin Cancer

Overview

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.

Interventions

  • Device Raman 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.
  • Device Raman 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.

Primary outcome measures

  • Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. [Time frame: 1 year]
Secondary outcome measures (2)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Stony Brook Hospital — Stony Brook

Identifiers

NCT: NCT06384924 · SBU-RAMAN-SKINCANCER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗