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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06384924
Other study ID # SBU-RAMAN-SKINCANCER
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 16, 2024
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source Stony Brook University
Contact Renee Cattell
Phone 631-216-9087
Email renee.cattell@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
United States Stony Brook Hospital Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Renee Cattell

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 1 year
Secondary Compare the size of clinically defined margin and Raman-defined margin 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). 1 year
Secondary Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin 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). 1 year
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