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)

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03179449

Enrollment

Registered

2017-06-07

Start date

2017-07-01

Completion date

2025-06-01

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Brain Neoplasm

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.

Interventions

DIAGNOSTIC_TESTDiagnostic (ferumoxytol-enhanced MRI)

Undergo ferumoxytol-enhanced MRI

PROCEDURESurgery

Undergo surgical resection

DRUGFerumoxytol

Given IV

OTHERTissue Analysis

Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Iron concentration measurements	Day 1	Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.

Secondary

Measure	Time frame	Description
Macrophages on histopathology	Days 2-4	Determine the number of macrophages in tissue samples at histopathology.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026