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

Childhood Brain Neoplasm Clinical Trial

Official title:

MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03179449
• Other study ID #: IRB-39245
• Secondary ID: NCI-2017-00959PE
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: July 1, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Childhood Brain Neoplasm

Intervention

Diagnostic Test:
• Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI

Procedure:
• Surgery
Undergo surgical resection

Drug:
• Ferumoxytol
Given IV

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Michael Iv	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron concentration measurements	Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.	Day 1
Secondary	Macrophages on histopathology	Determine the number of macrophages in tissue samples at histopathology.	Days 2-4