NCT00103038

Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases

NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

Detailed description

PRIMARY OBJECTIVES: I. Investigate the utility of ferumoxytol and gadolinium-based contrast agent (GBCA) for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast (DSC) determined relative cerebral blood volume (rCBV) and dynamic contrast enhancement (DCE) determined vascular permeability (derived transfer coefficient \[Ktrans\]). SECONDARY OBJECTIVES: I. Compare and evaluate magnetic resonance angiography (MRA) with ferumoxytol between different time points. II. Assess number and size of tumors imaged. III. Assess tumor vascularity. IV. Assess histology and electron microscopy (EM) on tissue samples. V. Assess differences in subjects with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy). VI. Assess the long term imaging characteristics of different tumors using DSC and DCE. OUTLINE: Patients receive ferumoxytol non-stoichiometric magnetite intravenously (IV) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients also undergo MRI without contrast at baseline and on day 2. Imaging with ferumoxytol, GBCA, and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. After completion of study, patients are followed up at approximately 4-6 weeks.

Conditions

• Central Nervous System Lymphoma
• Malignant Glioma
• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
PROCEDURE	3 Tesla Magnetic Resonance Imaging	Undergo 3T MRI
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo 3T DCE-MRI
PROCEDURE	Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging	Undergo 3T DSC-MRI
DRUG	Ferumoxytol	Given IV
DRUG	Gadolinium	Given IV
PROCEDURE	MRI-Based Angiogram	Undergo MRA

Timeline

• Start date: 2004-06-04
• Primary completion: 2016-05-10
• Completion: 2016-06-10
• First posted: 2005-02-08
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

1 site across 1 country: United States