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A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Patients With Malignant Brain Tumors Either Before or After Therapy

Phase 2
18 Years
75 Years
Open (Enrolling)
Brain Neoplasms

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Trial Information

A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Patients With Malignant Brain Tumors Either Before or After Therapy

Patients will be scanned either before or after treatment (radiation and/or chemotherapy).
There will be three visits on three consecutive days. On first day: MRI with and without
gadolinium (the usual MR contrast agent) infusion (0.1 mmol/kg). On second day: MRI with
ferumoxytol infusion (4 mg/kg). On the third day: MRI without additional contrast agent, 24
hr post ferumoxytol infusion. On the first and third day scans will be done in both magnets,
on the second day scans will be done either on 3T or 7T.

Various types of MR measurements (Perfusion, blood-brain barrier permeability, tumor volume)
will be measured using both contrast agents, in 3 and/or 7 Tesla. Certain regions will be
described and the data will be evaluated throughout the study. The tumor volume will be
evaluated by 2 radiologists, measuring the diameters of the largest areas of contrast
enhancement and signal intensities will be also compared (semi-quantitatively).

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed primary malignant brain
tumors or brain metastasis

- Patients must have had radiographically evaluable or measurable disease with standard
MR imaging, and the tumor must have an enhancing component.

- Patients may or may not have had prior surgery, radiation therapy, or chemotherapy.

- Age >18 years

- Men and women and members of all races and ethnic groups will be included.

- Life expectancy of greater than 2 weeks.

- ECOG performance status < 3.

- Ability to understand and the willingness to sign a written informed consent
document, or have a representative able to consent for the patient.

Exclusion Criteria:

- Subjects with clinically significant signs of uncal herniation

- Subjects who have a contraindication for MRI

- Subjects with known hepatic insufficiency or cirrhosis

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ferumoxytol

- Subjects with known or suspected iron overload (genetic hemochromatosis or history of
multiple transfusions)

- Patients expecting to undergo surgery between the imaging sessions. Patients may
undergo surgery at any time before the first, or after the last imaging session.

- 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 or lactating women are excluded from this study because of possible risk to
the fetus or infant.

- Inability or unwillingness to undergo the complete series of imaging sessions.
Inability or unwillingness to return to the neuro-oncology clinic at OHSU for the one
month follow-up.

- Known immunosuppression or immunodeficiency.

- Patients with stage IV or V renal insufficiency.

- Patients may not be receiving any other investigational agents.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary objective of this project is to compare quantitative imaging measures of brain tumor vascularity obtained from 3 T and 7T MRI instruments

Outcome Time Frame:

3 days

Safety Issue:


Principal Investigator

Edward A Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

December 2014

Related Keywords:

  • Brain Neoplasms
  • ferumoxytol
  • Diagnostic imaging
  • Brain Neoplasms
  • Neoplasms



Oregon Health & Science University Portland, Oregon  97201