Pilot Study of Raman Spectroscopic Imaging for Skin Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin(1 year)
- Compare the size of clinically defined margin and Raman-defined margin(1 year)
Investigators
Tiezhi Zhang
Medical Physicist, Clinical Assistant Professor
Stony Brook University