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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Michael Iv

Current Primary Outcome: Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. [ Time Frame: Day 1 ]

Original Primary Outcome: Analyze the imaging features on ferumoxytol-enhanced MRI using T1-, T2-, and T2*-weighted images including obtaining measurements of iron concentration of ferumoxytol [ Time Frame: Day 1 ]

Compared between groups using a two-way analysis of variance with a 0.05 significance level.


Current Secondary Outcome: Determine the number of macrophages in resected/biopsied samples at histopathology. [ Time Frame: Days 2-4 ]

Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: May 20, 2015
Date Started: June 10, 2015
Date Completion: May 2019
Last Updated: February 21, 2017
Last Verified: February 2017