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NCT Number: NCT02452216

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

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.

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Key information

Conditions

Brain Injury Brain Cancer Brain Diseases Brain Injuries Brain Neoplasms Brain Tumors Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Degenerative Disorder Central Nervous System Diseases Central Nervous System Infections Central Nervous System Infectious Disorder Central Nervous System Neoplasms Central Nervous System Vascular Malformation Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Hemorrhagic Cerebrovascular Accident Hemorrhagic Stroke Infections Ischemic Cerebrovascular Accident Ischemic Stroke Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Neurodegenerative Diseases Primary Brain Neoplasm Stroke Trauma, Nervous System Vascular Diseases Vascular Malformations Wounds and Injuries

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferumoxytol

Drug

Undergo ferumoxytol-enhanced MRI

Other names: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

Tissue Analysis

Other

Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Magnetic Resonance Imaging

Procedure

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Other names: Magnetic Resonance Imaging Scan, MRI

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

  1. Determine the number of macrophages in resected/biopsied samples at histopathology.

    Time frame: Days 2-4

Sponsors and collaborators

Lead sponsor

Michael Iv

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 22, 2015
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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