NCT03179449

In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael Iv · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.

Detailed description

PRIMARY OBJECTIVE: I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (\>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle. SECONDARY OBJECTIVES: I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology. OUTLINE: Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.

Conditions

• Childhood Brain Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic (ferumoxytol-enhanced MRI)	Undergo ferumoxytol-enhanced MRI
PROCEDURE	Surgery	Undergo surgical resection
DRUG	Ferumoxytol	Given IV
OTHER	Tissue Analysis	Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Timeline

• Start date: 2017-07-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2017-06-07
• Last updated: 2023-04-14

Regulatory

• FDA-regulated drug study