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

NCT ID: NCT00103038

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-04
• Study Completion Date: 2016-06-10

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI)

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

Group Type: EXPERIMENTAL

3 Tesla Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo 3T MRI

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo 3T DCE-MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo 3T DSC-MRI

Ferumoxytol

Intervention Type: DRUG

Given IV

Gadolinium

Intervention Type: DRUG

Given IV

MRI-Based Angiogram

Intervention Type: PROCEDURE

Undergo MRA

Interventions

3 Tesla Magnetic Resonance Imaging

Undergo 3T MRI

Intervention Type: PROCEDURE

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo 3T DCE-MRI

Intervention Type: PROCEDURE

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Undergo 3T DSC-MRI

Intervention Type: PROCEDURE

Ferumoxytol

Given IV

Intervention Type: DRUG

Gadolinium

Given IV

Intervention Type: DRUG

MRI-Based Angiogram

Undergo MRA

Intervention Type: PROCEDURE

Other Intervention Names

3 Tesla MRI; 3T MRI; DCE MRI; DCE-MRI; DYNAMIC CONTRAST ENHANCED MRI; Dynamic Susceptibility Contrast-Enhanced MRI; Feraheme; FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE; Gd; Magnetic Resonance Angiogram; MRA

Eligibility Criteria

Inclusion Criteria

• Subject must have either radiological or established histological diagnosis of the following general categories:

• High-grade glioma/central nervous system (CNS) lymphoma or
• Brain metastases
• Previously untreated subjects must have a lesion on an imaging study
• Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
• Subjects agree to be contacted 4-6 weeks after each study visit
• Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
• Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior

Exclusion Criteria

• Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
• Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2012); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
• Subjects who are pregnant or lactating or who suspect they might be pregnant
• Subjects who require monitored anesthesia for MRI scanning
• Subjects with renal insufficiency; glomerular filtration rate (GFR) < 50
• Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
• Subjects with known hepatic insufficiency or cirrhosis
• Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
• Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
• Subjects with three or more drug allergies from separate drug classes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Edward Neuwelt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Neuwelt

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2015-00226

Identifier Type: OTHER

Identifier Source: secondary_id

ONC-03095-LX

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00000813

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA137488

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00000813

Identifier Type: -

Identifier Source: org_study_id

NCT00980720

Identifier Type: -

Identifier Source: nct_alias