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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.

Ferumoxytol

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

Tissue Analysis

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Magnetic Resonance Imaging

Michael Iv, MD

This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.

In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.

Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI

Michael Iv

Clinical Assistant Professor

Rare Diseases

Brain Tumor, Childhood

Diagnostic (ferumoxytol-enhanced MRI)

Surgery

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.

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.

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)

Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.

Determine the number of macrophages in tissue samples at histopathology.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS	NCT02452216	Brain Injury Central Nervous... Central Nervous... Central Nervous... Hemorrhagic Cer... Ischemic Cerebr... Primary Brain N... Brain Cancer Brain Tumors	Ferumoxytol Tissue Analysis Magnetic Resona...	2 Years -	Stanford University
In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI	NCT03179449	Childhood Brain...	Diagnostic (fer... Surgery Ferumoxytol Tissue Analysis	2 Years -	Stanford University
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS	NCT02452216	Brain Injury Central Nervous... Central Nervous... Central Nervous... Hemorrhagic Cer... Ischemic Cerebr... Primary Brain N... Brain Cancer Brain Tumors	Ferumoxytol Tissue Analysis Magnetic Resona...	2 Years -	Stanford University
In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI	NCT03179449	Childhood Brain...	Diagnostic (fer... Surgery Ferumoxytol Tissue Analysis	2 Years -	Stanford University

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