Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS
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ClinicalTrials.gov Identifier: NCT02452216 |
Recruitment Status :
Completed
First Posted : May 22, 2015
Last Update Posted : August 31, 2017
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Condition or disease | Intervention/treatment | Phase |
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Brain Injury Central Nervous System Degenerative Disorder Central Nervous System Infectious Disorder Central Nervous System Vascular Malformation Hemorrhagic Cerebrovascular Accident Ischemic Cerebrovascular Accident Primary Brain Neoplasm Brain Cancer Brain Tumors | Drug: Ferumoxytol Other: Tissue Analysis Procedure: Magnetic Resonance Imaging | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI |
Actual Study Start Date : | June 10, 2015 |
Actual Primary Completion Date : | January 12, 2017 |
Actual Study Completion Date : | January 12, 2017 |

Arm | Intervention/treatment |
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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.
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Drug: Ferumoxytol
Undergo ferumoxytol-enhanced MRI
Other Names:
Other: Tissue Analysis Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion. Procedure: Magnetic Resonance Imaging All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
Other Names:
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- Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. [ Time Frame: Day 1 ]
- Determine the number of macrophages in resected/biopsied samples at histopathology. [ Time Frame: Days 2-4 ]

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452216
United States, California | |
Stanford University Hospitals and Clinics | |
Stanford, California, United States, 94305 |
Principal Investigator: | Michael Iv, MD | Stanford University Hospitals and Clinics |
Responsible Party: | Michael Iv, Clinical Assistant Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT02452216 |
Other Study ID Numbers: |
BRNCNS0007 NCI-2015-00435 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 26570 ( Other Identifier: Stanford IRB ) |
First Posted: | May 22, 2015 Key Record Dates |
Last Update Posted: | August 31, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Communicable Diseases Infections Central Nervous System Infections Brain Neoplasms Brain Injuries Stroke Ischemic Stroke Central Nervous System Vascular Malformations Hemorrhagic Stroke Vascular Malformations Disease Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Disease Attributes Congenital Abnormalities Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Cardiovascular Abnormalities Nervous System Malformations Ferrosoferric Oxide |