MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
Overview
- Phase
- Early Phase 1
- Intervention
- Diagnostic (ferumoxytol-enhanced MRI)
- Conditions
- Childhood Brain Neoplasm
- Sponsor
- Michael Iv
- Primary Endpoint
- Iron concentration measurements
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
PRIMARY OBJECTIVE: 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.
Investigators
Michael Iv
Clinical Assistant Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Diagnostic (ferumoxytol-enhanced MRI)
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.
Intervention: Surgery
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.
Intervention: Ferumoxytol
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.
Intervention: Tissue Analysis
Outcomes
Primary Outcomes
Iron concentration measurements
Time Frame: Day 1
Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.
Secondary Outcomes
- Macrophages on histopathology(Days 2-4)