Raman Spectroscopy and Skin Cancer

Официальное название

Pilot Study of Raman Spectroscopic Imaging for Skin Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. [Срок оценки: 1 year]

Вторичные конечные точки (2)

• Compare the size of clinically defined margin and Raman-defined margin [Срок оценки: 1 year]
• Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Stony Brook Hospital — Stony Brook

Идентификаторы

NCT: NCT06384924 · SBU-RAMAN-SKINCANCER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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