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Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
Sponsor: Stanford University
Summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 25 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-04
Completion Date
2028-12
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Panitumumab-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).
Pinpoint-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).
Explorer 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).
PDE-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).
Locations (1)
Stanford Cancer Center
Stanford, California, United States