Trial ID or NCT#

NCT01987375

Status

NOT RECRUITING

Purpose

This study is an open label, single institution, Phase 1 dose-escalation study to determine the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery that attaches to cancer cells and appears to make them visible to the doctor when he uses a special camera during the operation. The investigators are evaluating whether or not the use of the study drug along with the special camera will better identify the cancer while patients are in the operating room.

Official Title

Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

Eligibility Criteria

Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Eben Rosenthal
Otolaryngologist
Professor of Otolaryngology-Head and Neck Surgery and of Radiology (Molecular Imaging Program at Stanford)
Davud Sirjani
Otolaryngologist, Head and neck surgeon, Head and neck surgical oncologist
Clinical Associate Professor, Otolaryngology (Head and Neck Surgery)
Michael J. Kaplan
Head and neck surgical oncologist, Surgical oncologist, Head and neck surgeon, Otolaryngologist
Professor of Otolaryngology - Head and Neck Surgery and, by courtesy, of Neurosurgery at the Stanford University Medical Center
John B. Sunwoo
Thyroid and parathyroid surgeon, Cutaneous oncology specialist, Head and neck surgical oncologist, Head and neck surgeon, Endocrine surgeon, Surgical oncologist, Dermato-oncology specialist
Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology
Vasu Divi
Otolaryngologist, Head and neck surgical oncologist, Surgical oncologist, Head and neck surgeon
Associate Professor of Otolaryngology - Head and Neck Surgery at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

CCTO
(650) 498-7061