Ferumoxytol and Gadolinium Magnetic Resonance Imaging (MRI) at 3 Tesla (T) and 7 Tesla (T) in Patients With Malignant Brain Tumors
Conditions
Brain Neoplasms
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
ferumoxytol, Diagnostic imaging
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Ferumoxytol
Type: Drug
Overall Status
Recruiting
Summary
In this study the investigators would like to compare special magnetic resonance (MR) brain imaging techniques (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) in two different magnetic fields (3 and 7 Tesla) in the evaluation of brain tumors. Two contrast agents will be used; the standard gadolinium, and ferumoxytol, a new, iron containing agent. The investigators think that these new methods will give us better assessment of brain tumors.
Detailed Description
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 3 Tesla (T) or 7 Tesla (T).

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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.

- Eastern Cooperative Oncology Group (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 Oregon Health and Science University (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.
Location
Oregon Health & Science University
Portland, Oregon, United States
Status: Recruiting
Start Date
November 2006
Completion Date
May 2016
Sponsors
OHSU Knight Cancer Institute
Source
OHSU Knight Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page