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

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


Lead sponsor: Michael Iv

Collaborator: National Cancer Institute (NCI)

Source Stanford University
Brief 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


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.


I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.


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.

Overall Status Recruiting
Start Date July 1, 2017
Completion Date June 1, 2022
Primary Completion Date June 1, 2022
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Iron concentration measurements Day 1
Secondary Outcome
Measure Time Frame
Macrophages on histopathology Days 2-4
Enrollment 10

Intervention type: Diagnostic Test

Intervention name: Diagnostic (ferumoxytol-enhanced MRI)

Description: Undergo ferumoxytol-enhanced MRI

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Procedure

Intervention name: Surgery

Description: Undergo surgical resection

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Drug

Intervention name: Ferumoxytol

Description: Given IV

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Other

Intervention name: Tissue Analysis

Description: Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)



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: All

Minimum age: 2 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Michael Iv Principal Investigator Stanford University
Overall Contact

Last name: Vyvian Ngo

Phone: 408-890-9777

Email: [email protected]

facility status contact investigator Stanford University, School of Medicine Paymon Rezaii 650-743-8336 [email protected] Michael Iv Principal Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Stanford University

Investigator full name: Michael Iv

Investigator title: Clinical Assistant Professor

Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)