Clinical Research Directory

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

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.

Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.