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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

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

Treatments: Device: Reflectance Confocal Microscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02507141

15-128

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 1 patient group

SCC of the oral cavity scheduled for surgery

Description:

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.

Treatment:

Device: Reflectance Confocal Microscopy