Palo Alto, California 94304

  • Childhood Brain Neoplasm

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03179449


Primary Contact:

Principal Investigator
Michael Iv
Stanford University

Vyvian Ngo
Phone: 408-890-9777
Email: vyviann@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Paymon Rezaii
Phone: 650-743-8336
Email: prezaii@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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