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RECRUITING
NCT04085887
PHASE1/PHASE2

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Sponsor: Stanford University

View on ClinicalTrials.gov

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

DRUG

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).

DEVICE

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).

DEVICE

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).

DEVICE

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