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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Undergo 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.
Procedure: Magnetic Resonance Imaging
All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
- 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 ]
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|