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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (consent only)
Basking Ridge, New Jersey
Contact:
Snehal Patel, MD
212-639-3412

Memorial Sloan Kettering Monmouth (consent only)
Middletown, New Jersey 07748
Contact:
Snehal Patel, MD
212-639-3412

Memorial Sloan Kettering West Harrison (consent only)
Harrison, New York 10604
Contact:
Snehal Patel, MD
212-639-3412

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Snehal Patel, MD
212-639-3412

Memorial Sloan Kettering Nassau (consent only)
Uniondale, New York 11553
Contact:
Snehal Patel, MD
212-639-3412

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Snehal Patel, MD
212-639-3412