NCT03234309

Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors

High Resolution Steady State Blood Volume Maps in Pediatric Brain Tumors Using MRI

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies ferumoxytol in the magnetic resonance imaging of pediatric patients with brain tumors. Magnetic resonance imaging using ferumoxytol may help in viewing a brain tumor and blood vessels in and around the tumor in a different way than the standard gadolinium-based contrast agent. Imaging with this experimental contrast agent may give doctors more information about tumor blood supply and the extent of the tumor itself.

Detailed description

PRIMARY OBJECTIVE: I. Testing the superiority of ferumoxytol-based steady state (SS)-cerebral blood volume (CBV) maps over gadolinium-based contrast agent (GBCA)-based dynamic susceptibility weighted (DSC)-CBV maps in visualizing pediatric brain tumor blood volume maps. SECONDARY OBJECTIVES: I. Correlation of relative cerebral blood volume (rCBV) with histology and genetic markers. II. Assessment of therapeutic response. III. Assessment of late ferumoxytol enhancement at various stages of disease. OUTLINE: Patients undergo magnetic resonance imaging (MRI) with GBCA per standard of care over 45-60 minutes and then receive ferumoxytol intravenously (IV) followed by MRI over 10 minutes on day 1. Patients may optionally undergo MRI over 30 minutes without any contrast agent on day 2. Each study visit consisting of 2 days may repeat no more frequently than 4 weeks for up to 5 study visits at different stages of the disease as determined by the investigator. After completion of study, patients are followed up at 2 and 6 weeks and then periodically for 5 years.

Conditions

• Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Ferumoxytol	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2017-10-20
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2017-07-31
• Last updated: 2021-11-10

Regulatory

• FDA-regulated drug study