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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452216
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Iv, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
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.
Drug: Ferumoxytol
Undergo ferumoxytol-enhanced MRI
Other Names:
  • Feraheme
  • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

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:
  • Magnetic Resonance Imaging Scan
  • MRI




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

Secondary Outcome Measures :
  1. Determine the number of macrophages in resected/biopsied samples at histopathology. [ Time Frame: Days 2-4 ]


Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Michael Iv
Investigators
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Principal Investigator: Michael Iv, MD Stanford University Hospitals and Clinics

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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
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Brain Neoplasms
Brain Injuries
Stroke
Central Nervous System Vascular Malformations
Central Nervous System Infections
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
Congenital Abnormalities
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Nervous System Malformations
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions