Spots Global Cancer Trial Database for Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

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Trial Identification

Brief Title: Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Official Title: 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

Study ID: NCT03510208

Conditions

Malignant Brain Neoplasm

Malignant Glioma

Interventions

Near-Infrared Fluorescence Imaging

Panitumumab

Panitumumab-IRDye800

POINPOINT-IR9000

Study Description

Brief 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.