Clinical trial NCT00103038
Conditions: Central Nervous System Lymphoma Malignant Glioma Metastatic Malignant Neoplasm in the Brain
Sponsor: OHSU Knight Cancer Institute
Start date: 2004-06-04; Completion date: 2016-06-10
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer

Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) 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 will also undergo MRI without contrast at baseline (before 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.

3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI

Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI

Ferumoxytol: Given IV

Gadolinium: Given IV

MRI-Based Angiogram: Undergo MRA
Interventions: intervention 1: 3 Tesla Magnetic Resonance Imaging intervention 2: Dynamic Contrast-Enhanced Magnetic Resonance Imaging intervention 3: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging intervention 4: Ferumoxytol intervention 5: Gadolinium intervention 6: MRI-Based Angiogram
Intervention descriptions: intervention 1: Undergo 3T MRI intervention 2: Undergo 3T DCE-MRI intervention 3: Undergo 3T DSC-MRI intervention 4: Given IV intervention 5: Given IV intervention 6: Undergo MRA

Protocol documents: