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

Early Phase 1CompletedNCT02452216

Michael Iv10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Brain Injury Central Nervous System Degenerative Disorder

Interventions

FerumoxytolDRUG

Undergo ferumoxytol-enhanced MRI

Tissue AnalysisOTHER

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

Magnetic Resonance ImagingPROCEDURE

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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient with suspected brain tumor diagnosed by MRI * Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases) Exclusion Criteria: * Informed consent cannot be obtained either from the patient or legal representative * Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study * Contraindication to MRI (metal implants) * Hemosiderosis/hemochromatosis * Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned) * Known hypersensitivity to Feraheme (ferumoxytol) or any of its components * 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

Outcomes

Primary Outcomes

Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.

Time frame: Day 1

Secondary Outcomes

Determine the number of macrophages in resected/biopsied samples at histopathology.

Time frame: Days 2-4