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Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:
A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03582124
Study type Interventional
Source Stanford University
Contact Roan C Raymundo
Phone 650-721-4071
Email rcraymun@stanford.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date July 19, 2018
Completion date February 2027
View Details
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