Skin CancerNCT06384924
Raman Spectroscopy and Skin Cancer
An observational study of Skin Cancer and Basal Cell Carcinoma, run by Tiezhi Zhang at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Raman Spectroscopy handheld probe (EmVision, FL, USA) and Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 13 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will include patients with confirmed skin cancer.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook Hospital
Stony Brook, New York, 11794
Renee Cattell, PhD, renee.farrell@stonybrookmedicine.edu
Renee Cattell, PhD
About this study
Official title: Pilot Study of Raman Spectroscopic Imaging for Skin Cancer
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.
Read the 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.
- Conditions
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- Raman Spectroscopy handheld probe (EmVision, FL, USA), Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman Spectroscopy handheld probe (EmVision, FL, USA)Device
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)Device
This light source will create the laser light that will pass through the cable and through the handheld probe onto the skin.
| Study group | Role | What they receive |
|---|---|---|
| Raman Spectroscopy | Not described Receives: Device: Raman Spectroscopy handheld probe (EmVision, FL, USA); Device: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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).
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start13 Feb 2025
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiezhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tiezhi Zhang, Stony Brook University
- Investigators
- Tiezhi Zhang, Principal investigator, Stony Brook Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384924
- Sponsor's protocol ID
- SBU-RAMAN-SKINCANCER
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Raman Spectroscopic Imaging for Skin Cancer
- ClinicalTrials.gov ID
- NCT06384924
- Acronym / sponsor ID
- SBU-RAMAN-SKINCANCER
- Conditions
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tiezhi ZhangUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raman Spectroscopy | – | Device: Raman Spectroscopy handheld probe (EmVision, FL, USA), Device: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include patients with confirmed skin cancer.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Raman Spectroscopy |
| 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. | Device | Raman Spectroscopy |
Primary outcome
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.
2 secondary outcomes
Compare the size of clinically defined margin and Raman-defined margin
Time frame: 1 year
Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiezhi Zhang principal investigator
Stony Brook Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Basal Cell Carcinoma, run by Tiezhi Zhang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiezhi Zhang (631-444-3617, tiezhi.zhang@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.