NCT03510208

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.

Detailed description

PRIMARY OBJECTIVES: I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma. SECONDARY OBJECTIVES: I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue. II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio. III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio. OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.

Conditions

• Malignant Brain Neoplasm
• Malignant Glioma

Interventions

Type	Name	Description
PROCEDURE	Near-Infrared Fluorescence Imaging	Undergo NIR imaging
BIOLOGICAL	Panitumumab	Given IV
DRUG	Panitumumab-IRDye800	Given IV
DEVICE	POINPOINT-IR9000	Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite ("back table").

Timeline

• Start date: 2018-05-16
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2018-04-27
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

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