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

Early Phase 1

Completed

• Conditions: Central Nervous System Vascular Malformation; Hemorrhagic Cerebrovascular Accident; Brain Cancer; Brain Tumors; Ischemic Cerebrovascular Accident; Central Nervous System Infectious Disorder; Brain Injury; Central Nervous System Degenerative Disorder; Primary Brain Neoplasm
• Interventions: Drug: Ferumoxytol; Other: Tissue Analysis; Procedure: Magnetic Resonance Imaging

• Registration Number: NCT02452216
• Lead Sponsor: Michael Iv

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.

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 Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Study Start: 2015-06-10
• Primary Completion: 2017-01-12
• Study Completion: 2017-01-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferumoxytol group	Magnetic Resonance Imaging	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 group	Tissue Analysis	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 group	Ferumoxytol	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Determine the number of macrophages in resected/biopsied samples at histopathology.	Days 2-4

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States