Panitumumab-IRDye800 for Pediatric Brain Tumor Surgery

This study is looking at the safety of a new imaging agent called Panitumumab-IRDye800 in children and young adults (ages 6 months to 25 years) who are having surgery to remove suspected brain tumors. Panitumumab-IRDye800 is a special dye that helps surgeons see tumor tissue better during an operation. Researchers want to find the best dose of this agent and see how well it helps detect very small pieces of tumor that might be left behind. You may be able to join if you have a suspected brain tumor and are scheduled for surgery to remove it. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is an interventional study with a planned enrollment of 12 participants, focusing on the safety and effectiveness of Panitumumab-IRDye800.
What's involved
You would receive an infusion of Panitumumab-IRDye800 1 to 5 days before your surgery. Imaging will be performed during surgery and on the removed tissue.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 30 days after the study infusion, with visits on the day of surgery, Day 15, and Day 30.

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NCT04085887

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Recruiting
PHASE1Ages 6–25InterventionalDiagnostic
Stanford University
~12 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Panitumumab-IRDye800Pinpoint-IR9000 endoscopic/handheld deviceExplorer Air cameraPDE-NEO-II

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicities (related adverse events)
Measured over 30 days
Brain Tumor
1 sites across 1 states
California1
  • Laura Prolo, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
Subjects must be eligible for resection as determined by the operating surgeon.
Planned standard of care surgery
Subject age 6 months to 25 years
Life expectancy of more than 12 weeks

Exclusion

Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
History of infusion reactions to monoclonal antibody therapies
Pregnant or breastfeeding
Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
Magnesium, potassium and calcium \< the lower limit of normal per institution normal lab values
Serum creatinine \> 1.5 times upper reference range
Other lab values that in the opinion of the primary surgeon would prevent surgical resection
Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here
  • Toxicities (related adverse events)30 days

    Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.