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Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

NCT04085887 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-20

No results posted yet for this study

Summary

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

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).

Sponsors & Collaborators

Principal Investigators

  • Laura Prolo, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085887 on ClinicalTrials.gov