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RecruitingObservational

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

NCT ID: NCT02507141Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-03-16

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. 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.

Arms & interventions

  • DeviceReflectance Confocal Microscopy

    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.

Outcome measures

Primary

  • 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.

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 Criteria: * 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.

Study locations (5)

Memorial Sloan Kettering Basking Ridge (consent only)

Basking Ridge, New Jersey

Recruiting
Snehal Patel, MD · Contact

Memorial Sloan Kettering Monmouth (consent only)

Middletown, New Jersey, 07748

Recruiting
Snehal Patel, MD · Contact

Memorial Sloan Kettering West Harrison (consent only)

Harrison, New York, 10604

Recruiting
Snehal Patel, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Snehal Patel, MD · Contact
Milind Rajadhyaksha, PhD · Contact
Snehal Patel, MD · Principal Investigator

Memorial Sloan Kettering Nassau (consent only)

Uniondale, New York, 11553

Recruiting
Snehal Patel, MD · Contact