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Reflectance Confocal Microscopy for Oral Cancers

This study is looking at a new way to take pictures of oral lesions (sores or abnormal areas in the mouth) using a special camera called Reflectance Confocal Microscopy (RCM). This camera uses a laser to take detailed pictures of tissue at a microscopic level. The goal is to see if these pictures can help doctors diagnose oral cancers earlier and guide surgery. If you have oral squamous cell carcinoma (a type of head and neck cancer) that has been confirmed by a biopsy and you are scheduled for surgery, you might be able to join. The study will compare the RCM images with your biopsy results to see how well the technology works. This is an observational study, meaning researchers are watching and collecting information, not testing a new treatment. The current status of the study is unclear.

Study design
This is an observational study planning to include up to 140 participants. Researchers will collect information and images without testing a new treatment.
What's involved
If you join, Reflectance Confocal Microscopy imaging will be done during your surgery, which should take no more than 15-20 minutes.
Compensation
Not stated in the trial record.
Follow-up
The RCM images will be measured at 1 year, suggesting a follow-up period.

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NCT02507141

Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~140 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Reflectance Confocal Microscopy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reflectance Confocal Microscopy (RCM) images
Measured over 1 year

Conditions

Head and Neck Cancer
Squamous Cell Carcinoma (SCC) of the Oral Cavity

Explore related trials

Oral Cavity Squamous Cell Carcinoma

Where it's being run

5 sites across 2 states
New York3
New Jersey2

Study leadership

  • Snehal Patel, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Snehal Patel, MD
212-639-3412
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Reflectance Confocal Microscopy (RCM) images1 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.