MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy

NCT00769093

Brain Neoplasms

TERMINATED PHASE1

Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT04574856

Glioblastoma

ACTIVE_NOT_RECRUITING PHASE2

Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme

NCT02663440

Glioblastoma Multiforme

UNKNOWN PHASE2

A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma

NCT00792012

Glioblastoma Multiforme

COMPLETED PHASE1

A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma

NCT02805179

Glioma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.

II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.

SECONDARY OBJECTIVES:

I. Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.

II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.

III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.

OUTLINE:

Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.

After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Brain Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ferumoxytol

Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity.

Group Type EXPERIMENTAL

Ferumoxytol Non-Stoichiometric Magnetite

Intervention Type DRUG

Given IV

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DCE MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DSC MRI

Diffusion Weighted Imaging

Intervention Type OTHER

Undergo DWI

MRI-Based Angiogram

Intervention Type OTHER

Undergo TOF MR angiography

Gadoteridol

Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).

Group Type ACTIVE_COMPARATOR

Gadolinium

Intervention Type DRUG

Given IV

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DCE MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DSC MRI

Diffusion Weighted Imaging

Intervention Type OTHER

Undergo DWI

MRI-Based Angiogram

Intervention Type OTHER

Undergo TOF MR angiography

Gadoteridol Leakage Corrected

Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).

Group Type ACTIVE_COMPARATOR

Gadolinium

Intervention Type DRUG

Given IV

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DCE MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type OTHER

Undergo DSC MRI

Diffusion Weighted Imaging

Intervention Type OTHER

Undergo DWI

MRI-Based Angiogram

Intervention Type OTHER

Undergo TOF MR angiography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gadolinium

Given IV

Intervention Type DRUG

Ferumoxytol Non-Stoichiometric Magnetite

Given IV

Intervention Type DRUG

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE MRI

Intervention Type OTHER

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Undergo DSC MRI

Intervention Type OTHER

Diffusion Weighted Imaging

Undergo DWI

Intervention Type OTHER

MRI-Based Angiogram

Undergo TOF MR angiography

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Gd Fe3O4 Feraheme Ferumoxytol DCE MRI DCE-MRI DSC-MRI Dynamic Susceptibility Contrast-Enhanced MRI Diffusion Weighted MRI DWI DWI MRI DWI-MRI Magnetic Resonance Angiogram MRA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme
* Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views
* Life expectancy of greater than 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%)
* Patients scheduled for standard therapy (6 weeks radiation therapy (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week \[w\] RT, and followed routine monthly temozolomide therapy)
* Patients must be on a stable or decreasing dose (up to 8 mg daily) of dexamethasone throughout the study
* After entry into the study, patients are expected to be followed for at least 1 month after the last infusion of ferumoxytol
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria

* Patients who have had chemotherapy or radiotherapy
* Patients may not be receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
* Patients 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
* Patients who require monitored anesthesia for MRI scanning
* Patients with history of hemochromatosis or iron overload
* Patients with renal insufficiency (glomerular filtration rate (GFR) \< 50)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ferumoxytol
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Edward Neuwelt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Neuwelt

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States