Clinical trial NCT06384924: Raman Spectroscopy and Skin Cancer
Official title: Pilot Study of Raman Spectroscopic Imaging for Skin Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include patients with confirmed skin cancer.

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.

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.

Primary outcomes:
measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin.
timeFrame: 1 year
Secondary outcomes:
measure: Compare the size of clinically defined margin and Raman-defined margin
timeFrame: 1 year
measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin
timeFrame: 1 year
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Hospital
state: New York
Study officials:
affiliation: Stony Brook Cancer Center
name: Renee Farrell
role: PRINCIPAL_INVESTIGATOR
References: