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


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.

Full Title of Study: “MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2025

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.


  • 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.

Arms, Groups and Cohorts

  • Experimental: Diagnostic (ferumoxytol-enhanced MRI)
    • All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.

Clinical Trial Outcome Measures

Primary Measures

  • Iron concentration measurements
    • Time Frame: Day 1
    • Obtain susceptibility measurements and relaxation times (R2, R2*, R2′) in patients receiving ferumoxytol.

Secondary Measures

  • Macrophages on histopathology
    • Time Frame: Days 2-4
    • Determine the number of macrophages in tissue samples at histopathology.

Participating in This Clinical Trial

Inclusion Criteria

  • Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection Exclusion Criteria:

  • Informed consent cannot be obtained either from the patient or legal representative – Severe coexisting or terminal systemic disease that may interfere with the conduct of the study – Contraindication to MRI (metal implants) – Hemosiderosis/hemochromatosis – Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology – Known hypersensitivity to ferumoxytol or any of its components – Pregnant patients

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Michael Iv
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Michael Iv, Clinical Assistant Professor – Stanford University
  • Overall Official(s)
    • Michael Iv, Principal Investigator, Stanford University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.