Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
Start Date
7/19/2018
Completion Date
9/1/2026
Summary
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio. SECONDARY OBJECTIVES: I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer. II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging. OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study. Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days. After completion of study treatment, participants are followed up for up to 30 days.
Eligibility Criteria
Age Range: 19 years to No maximum
Interventions
Near-Infrared Fluorescence Imaging
Panitumumab-IRDye800
Pharmacokinetic Study
Therapeutic Conventional Surgery
Conditions
Locations
Stanford University, School of Medicine
Palo Alto, California 94304
United States