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

Completed

Phase Early 1 Results N/A

Trial Description

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

Interventions

  • Magnetic Resonance Imaging Procedure
    Other Names: Magnetic Resonance Imaging Scan; MRI
    Intervention Desc: All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
    ARM 1: Kind: Experimental
    Label: Ferumoxytol-enhanced MRI
    Description: Single dose of ferumoxytol (5 mg Fe/kg) to be administered 24 hours before MRI
    ARM 2: Kind: Experimental
    Label: Ferumoxytol group
    Description: 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 Drug
    Other Names: Feraheme; FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
    Intervention Desc: Undergo ferumoxytol-enhanced MRI
    ARM 1: Kind: Experimental
    Label: Ferumoxytol-enhanced MRI
    Description: Single dose of ferumoxytol (5 mg Fe/kg) to be administered 24 hours before MRI
    ARM 2: Kind: Experimental
    Label: Ferumoxytol group
    Description: 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.
  • Tissue Analysis Other
    Intervention Desc: Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
    ARM 1: Kind: Experimental
    Label: Ferumoxytol-enhanced MRI
    Description: Single dose of ferumoxytol (5 mg Fe/kg) to be administered 24 hours before MRI
    ARM 2: Kind: Experimental
    Label: Ferumoxytol group
    Description: 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.

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Analyze the imaging features on ferumoxytol-enhanced MRI using T1-, T2-, and T2*-weighted images including obtaining measurements of iron concentration of ferumoxytol Day 1 No
Secondary Determine the number of macrophages in resected/biopsied samples at histopathology. Days 2-4 No
Primary Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. Day 1 No

Sponsors