Recruiting

Intra-oral Imaging

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT02507141

Conditions

Head and Neck Cancer

Squamous Cell Carcinoma (SCC) of the Oral Cavity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reflectance Confocal Microscopy

Study Details

Brief 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.

Conditions

Head and Neck Cancer

Squamous Cell Carcinoma (SCC) of the Oral Cavity

Study ID

NCT02507141

Start date

Jul 21, 2015

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Reflectance 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.

Primary outcome measure

  • Reflectance Confocal Microscopy (RCM) images [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Snehal Patel, MD

212-639-3412

Milind Rajadhyaksha, PhD

646-888-6243

Locations

Memorial Sloan Kettering Basking Ridge (consent only)

Recruiting

Basking Ridge, New Jersey, United States

Contacts

Snehal Patel, MD

212-639-3412

Memorial Sloan Kettering Monmouth (consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Snehal Patel, MD

212-639-3412

Memorial Sloan Kettering West Harrison (consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Snehal Patel, MD

212-639-3412

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Snehal Patel, MD

212-639-3412

Milind Rajadhyaksha, PhD

646-888-6243

Principal Investigator:

Snehal Patel, MD

Memorial Sloan Kettering Nassau (consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Snehal Patel, MD

212-639-3412

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Reflectance Confocal Microscopy
  • 15-128

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-04.