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

Sponsor

Michael Iv (Other)

Overall Status

Completed

CT.gov ID

NCT02452216

Collaborator

(none)

Enrollment

Location

Arm

19.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injury Central Nervous System Degenerative Disorder Central Nervous System Infectious Disorder Central Nervous System Vascular Malformation Hemorrhagic Cerebrovascular Accident Ischemic Cerebrovascular Accident Primary Brain Neoplasm Brain Cancer Brain Tumors	Drug: Ferumoxytol Other: Tissue Analysis Procedure: Magnetic Resonance Imaging	Early Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 10, 2015

Actual Primary Completion Date :

Jan 12, 2017

Actual Study Completion Date :

Jan 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferumoxytol group 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.	Drug: Ferumoxytol Undergo ferumoxytol-enhanced MRI Other Names: Feraheme FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE Other: Tissue Analysis Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion. Procedure: Magnetic Resonance Imaging All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI. Other Names: Magnetic Resonance Imaging Scan MRI

Arm

Intervention/Treatment

Experimental: Ferumoxytol group

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.

Drug: Ferumoxytol

Undergo ferumoxytol-enhanced MRI

Other Names:

Feraheme

FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

Other: Tissue Analysis

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

Procedure: Magnetic Resonance Imaging

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

Other Names:

Magnetic Resonance Imaging Scan

MRI

Outcome Measures

Primary Outcome Measures

Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. [Day 1]

Secondary Outcome Measures

Determine the number of macrophages in resected/biopsied samples at histopathology. [Days 2-4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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