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



Status:Completed
Conditions:Cancer, Brain Cancer, Infectious Disease, Neurology, Neurology, Neurology, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Neurology, Oncology, Reproductive
Healthy:No
Age Range:2 - Any
Updated:9/1/2017
Start Date:June 10, 2015
End Date:January 12, 2017

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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.

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.

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
We found this trial at
1
site
900 Quarry Road Extension
Stanford, California 94305
(650) 723-5111
Principal Investigator: Michael Iv, MD
Phone: 650-723-4527
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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Stanford, CA
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