RecruitingPhase 1Phase 2NCT03510208

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


Sponsor

Stanford University

Enrollment

46 participants

Start Date

May 16, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a specially tagged antibody called panitumumab-IRDye800 that glows under a special light during surgery, helping surgeons more precisely identify and remove brain tumor tissue (glioblastoma) or a type of benign nerve tumor (vestibular schwannoma). **You may be eligible if...** - You are 18 years or older - You have been diagnosed or are suspected to have glioblastoma (a serious brain tumor) or a vestibular schwannoma (a benign tumor near the ear/balance nerve) - Surgery to remove the tumor is planned as part of your standard treatment - You are willing and able to attend all required visits and follow the study plan **You may NOT be eligible if...** - You have received an experimental drug in the past 30 days - You have had a heart attack, stroke, or serious heart or liver condition in the past 6 months - You have previously had a severe reaction to a monoclonal antibody (a type of targeted therapy) - You are pregnant or breastfeeding - Your ECG shows a specific heart rhythm abnormality - Certain blood test values are outside the acceptable range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENear-Infrared Fluorescence Imaging

Undergo NIR imaging

BIOLOGICALPanitumumab

Given IV

DRUGPanitumumab-IRDye800

Given IV

DEVICEPOINPOINT-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").


Locations(1)

Stanford University School of Medicine

Palo Alto, California, United States

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NCT03510208


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