Raman Spectroscopy and Skin Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTiezhi Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The population will include patients with confirmed skin cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Raman Spectroscopy handheld probe (EmVision, FL, USA)
DeviceThe 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)
DeviceThis light source will create the laser light that will pass through the cable and through the handheld probe onto the skin.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Raman Spectroscopy2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 yearSecondary outcomes
1
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).
Time frame
1 year2
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).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tiezhi Zhang
Lead sponsor
Stony Brook University
Sponsor institution
Source ClinicalTrials.gov