NCT02452216

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Michael Iv · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Ferumoxytol	Undergo ferumoxytol-enhanced MRI
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.

Timeline

• Start date: 2015-06-10
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2015-05-22
• Last updated: 2017-08-31

Locations

1 site across 1 country: United States