Head and Neck CancerNCT02507141
Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
An observational study of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma (SCC) of the Oral Cavity
- What is being tested?
- Reflectance Confocal Microscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Jul 2015to Jul 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: Potential research subjects in the Head and Neck Service will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan Kettering Cancer Center (MSK).
Who may be able to join
- Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
- Ability to sign informed consent.
- Age ≥ 18 years.
Who cannot join
- Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
- Inability to give informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Snehal Patel, MD contact
Milind Rajadhyaksha, PhD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (consent only)
Basking Ridge, New Jersey
Snehal Patel, MD, 212-639-3412
- Recruiting
Memorial Sloan Kettering West Harrison (consent only)
Harrison, New York, 10604
Snehal Patel, MD, 212-639-3412
- Recruiting
Memorial Sloan Kettering Monmouth (consent only)
Middletown, New Jersey, 07748
Snehal Patel, MD, 212-639-3412
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Snehal Patel, MD, 212-639-3412
Milind Rajadhyaksha, PhD, 646-888-6243
- Recruiting
Memorial Sloan Kettering Nassau (consent only)
Uniondale, New York, 11553
Snehal Patel, MD, 212-639-3412
About this study
The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.
- Being tested
- Reflectance Confocal Microscopy
- Keywords
- Reflectance Confocal Microscopy, 15-128
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflectance Confocal MicroscopyDevice
Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.
| Study group | Role | What they receive |
|---|---|---|
| SCC of the oral cavity scheduled for surgery | The patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery. Receives: Device: Reflectance Confocal Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflectance Confocal Microscopy (RCM) images
Each set of images and the corresponding pathology will be evaluated by the study pathologist for the presence or absence of oral SCC. All images will be evaluated as a group. First, the pathologist will review the RCM images for each imaging site and will determine the presence/absence of tumor. Next, the pathologist will review the corresponding histopathologic material for the presence/absence of tumor. If there is discordance in the evaluations, the pathologist will re-evaluate the RCM images with the corresponding pathology, in a side-by-side manner, to highlight any features that may assist in the RCM evaluation.
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 posted23 Jul 2015 (estimated)
- Study start21 Jul 2015
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snehal Patel, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507141
- Sponsor's protocol ID
- 15-128
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2015
- Last updated
- 4 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
- ClinicalTrials.gov ID
- NCT02507141
- Acronym / sponsor ID
- 15-128
- Keywords
- Reflectance Confocal Microscopy, 15-128
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- 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 purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCC of the oral cavity scheduled for surgery | – | Device: Reflectance Confocal MicroscopyThe patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects in the Head and Neck Service will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan Kettering Cancer Center (MSK).
Key inclusion criteria (3 listed)
- Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
- Ability to sign informed consent.
- Age ≥ 18 years.
Key exclusion criteria (2 listed)
- Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
- Inability to give informed consent.
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 |
|---|---|---|
| Reflectance Confocal MicroscopyReflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service. | Device | SCC of the oral cavity scheduled for surgery |
Primary outcome
Reflectance Confocal Microscopy (RCM) images
Time frame: 1 year
Each set of images and the corresponding pathology will be evaluated by the study pathologist for the presence or absence of oral SCC. All images will be evaluated as a group. First, the pathologist will review the RCM images for each imaging site and will determine the presence/absence of tumor. Next, the pathologist will review the corresponding histopathologic material for the presence/absence of tumor. If there is discordance in the evaluations, the pathologist will re-evaluate the RCM images with the corresponding pathology, in a side-by-side manner, to highlight any features that may assist in the RCM evaluation.
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 4 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Snehal Patel, MD contact
Milind Rajadhyaksha, PhD contact
Snehal Patel, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Squamous Cell Carcinoma (SCC) of the Oral Cavity, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 2 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Snehal Patel, MD (212-639-3412), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflectance Confocal Microscopy (RCM) images (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 4 Aug 2026.