RecruitingPhase 1Phase 2NCT04085887

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures

Sponsor

Stanford University

Enrollment

12 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Brain Tumor

Summary

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Eligibility

Min Age: 6 MonthsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special glowing dye (panitumumab-IRDye800) that helps surgeons see brain tumor tissue more clearly during surgery in children and young adults. When exposed to a special light, the dye lights up cancer cells so surgeons can remove more tumor while protecting healthy brain tissue. **You may be eligible if...** - You are between 6 months and 25 years old - You have a suspected brain tumor that requires surgical removal as part of standard care - Your surgeon believes surgery is appropriate for you - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You received an experimental drug within the past 30 days - You have a recent history of heart attack, stroke, heart failure, or severe liver disease (within 6 months) - You have had a serious reaction to a monoclonal antibody treatment before - You are pregnant or breastfeeding - You have abnormal heart rhythm readings (QTc prolongation) - Your kidney function is abnormal 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

DRUGPanitumumab-IRDye800

Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).

DEVICEPinpoint-IR9000 endoscopic/handheld device

Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

DEVICEExplorer Air camera

Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

DEVICEPDE-NEO-II

Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).