Study Stopped
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In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
4 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2017
Longer than P75 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 14, 2023
April 1, 2023
7.9 years
June 5, 2017
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Iron concentration measurements
Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.
Day 1
Secondary Outcomes (1)
Macrophages on histopathology
Days 2-4
Study Arms (1)
Diagnostic (ferumoxytol-enhanced MRI)
EXPERIMENTALAll 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.
Interventions
Undergo ferumoxytol-enhanced MRI
Given IV
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
Eligibility Criteria
You may qualify if:
- Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection
You may not qualify if:
- Informed consent cannot be obtained either from the patient or legal representative
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Ivlead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Iv
Stanford University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 7, 2017
Study Start
July 1, 2017
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
April 14, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share