In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
NCT ID: NCT03179449
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2017-07-01
2025-06-01
Brief Summary
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Detailed Description
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I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (\>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
SECONDARY OBJECTIVES:
I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.
OUTLINE:
Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (ferumoxytol-enhanced MRI)
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.
Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
Surgery
Undergo surgical resection
Ferumoxytol
Given IV
Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
Interventions
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Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
Surgery
Undergo surgical resection
Ferumoxytol
Given IV
Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
* Contraindication to MRI (metal implants)
* Hemosiderosis/hemochromatosis
* 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
* Known hypersensitivity to ferumoxytol or any of its components
* Pregnant patients
2 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Michael Iv
OTHER
Responsible Party
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Michael Iv
Clinical Assistant Professor
Principal Investigators
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Michael Iv
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Other Identifiers
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NCI-2017-00959
Identifier Type: REGISTRY
Identifier Source: secondary_id
PEDSBRNCNS0008
Identifier Type: OTHER
Identifier Source: secondary_id
PEDSBRNCNS0008
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-39245
Identifier Type: -
Identifier Source: org_study_id
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