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

August 30, 2017 updated by: Michael Iv

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Iv

Investigators

  • Principal Investigator: Michael Iv, MD, Stanford University Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2015

Primary Completion (Actual)

January 12, 2017

Study Completion (Actual)

January 12, 2017

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRNCNS0007
  • NCI-2015-00435 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 26570 (Other Identifier: Stanford IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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