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

NCT00103038 | Completed Results DMC

• 4 other identifiers: IRB00000813NCI-2015-00226ONC-03095-LXR01CA137488
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans)

  Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.

  Assessed after each visit for up to 6 imaging sessions (up to 5 years)

• Utility of Ferumoxytol and Gadolinium Based Contrast Agents 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) Maps.

  Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).

  Summarized after completion of up to 6 imaging sessions (up to 5 years)

Secondary Outcomes (3)

• Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume)

  Summarized after completion of up to 6 imaging sessions (up to 5 years)

• Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)

  Summarized after completion of up to 6 imaging sessions (up to 5 years)

• Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI

  Assessed after each visit for up to 6 imaging sessions (up to 5 years)

Study Arms (1)

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

EXPERIMENTAL

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

Procedure: 3 Tesla Magnetic Resonance Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol; Drug: Gadolinium; Procedure: MRI-Based Angiogram

Interventions

3 Tesla Magnetic Resonance Imaging PROCEDURE

Undergo 3T MRI

Also known as: 3 Tesla MRI, 3T MRI

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

Dynamic Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo 3T DCE-MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

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

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo 3T DSC-MRI

Also known as: Dynamic Susceptibility Contrast-Enhanced MRI

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

Ferumoxytol DRUG

Given IV

Also known as: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

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

Gadolinium DRUG

Given IV

Also known as: Gd

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

MRI-Based Angiogram PROCEDURE

Undergo MRA

Also known as: Magnetic Resonance Angiogram, MRA

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Ferrosoferric Oxide; Gadolinium

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Metals

Results Point of Contact

• Title: Gerda Teglassy, MD
• Organization: Oregon Health and Science University

tothg@ohsu.edu

5034945626

Study Officials

• Edward Neuwelt

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: June 4, 2004
• Primary Completion: May 10, 2016
• Study Completion: June 10, 2016
• Last Updated: June 9, 2022
• Results First Posted: June 9, 2022

Record last verified: 2022-05

Locations

US (1)