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

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

Sponsors

Lead sponsor: Michael Iv

Collaborator: National Cancer Institute (NCI)

Source Stanford University
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.

Overall Status Recruiting
Start Date July 1, 2017
Completion Date June 1, 2022
Primary Completion Date June 1, 2022
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Iron concentration measurements Day 1
Secondary Outcome
Measure Time Frame
Macrophages on histopathology Days 2-4
Enrollment 10
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Diagnostic (ferumoxytol-enhanced MRI)

Description: Undergo ferumoxytol-enhanced MRI

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Procedure

Intervention name: Surgery

Description: Undergo surgical resection

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Drug

Intervention name: Ferumoxytol

Description: Given IV

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Intervention type: Other

Intervention name: Tissue Analysis

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

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

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

Gender: All

Minimum age: 2 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Michael Iv Principal Investigator Stanford University
Overall Contact

Last name: Vyvian Ngo

Phone: 408-890-9777

Email: [email protected]

Location
facility status contact investigator Stanford University, School of Medicine Paymon Rezaii 650-743-8336 [email protected] Michael Iv Principal Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Stanford University

Investigator full name: Michael Iv

Investigator title: Clinical Assistant Professor

Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Diagnostic (ferumoxytol-enhanced MRI)

Arm group type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov