In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

Michael Iv

Status and phase: Withdrawn; Early Phase 1

Conditions: Childhood Brain Neoplasm

Treatments: Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI); Procedure: Surgery; Other: Tissue Analysis; Drug: Ferumoxytol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03179449

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2017-00959 (Registry Identifier)

IRB-39245

PEDSBRNCNS0008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (ferumoxytol-enhanced MRI)

Experimental group

Description:

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.

Treatment:

Drug: Ferumoxytol

Other: Tissue Analysis

Procedure: Surgery

Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI)