NCT02415881

Panitumumab IRDye800 Optical Imaging Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Eben Rosenthal · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Detailed description

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab IRDye 800	Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery
DEVICE	da Vinci Firefly	Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)
DEVICE	IMAGE1 + ICG Hopkins telescope and/or VITOM	IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-11-23
• Completion: 2021-09-21
• First posted: 2015-04-14
• Last updated: 2021-09-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study