Ferumoxytol and Gadolinium Magnetic Resonance Imaging (MRI) at 3T and 7T in Patients With Malignant Brain Tumors

This study is currently recruiting participants.
Verified July 2013 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00659126
First received: April 10, 2008
Last updated: July 30, 2013
Last verified: July 2013

April 10, 2008
July 30, 2013
November 2006
May 2014   (final data collection date for primary 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 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00659126 on ClinicalTrials.gov Archive Site
  • To compare blood brain barrier permeabilities of Ferumoxytol and a standard gadolinium based MRI contrast agent. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • To compare cerebral blood volume (CBV) measurements obtained using a standard gadolinium MRI contrast agent and ferumoxytol CBV will be quantified using dynamic susceptibility contrast (DSC) techniques using both Gd and Ferumoxytol contrast agents. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • To compare perfusion and permeability parameters between treated and untreated patients [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • To determine the microscopic distribution of ferumoxytol particles in tissue removed from patients undergoing surgery. . [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ferumoxytol and Gadolinium Magnetic Resonance Imaging (MRI) at 3T and 7T in Patients With Malignant Brain Tumors
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

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.

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).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Neoplasms
Drug: Ferumoxytol
4mg/kg
Other Name: Ferumoxytol
  • Active Comparator: 1
    MR imaging at 3T
    Intervention: Drug: Ferumoxytol
  • Active Comparator: 2
    MR imaging at 7T
    Intervention: Drug: Ferumoxytol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
May 2015
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu
Contact: Cynthia A Lacy, BSN 503-494-5626 lacyc@ohsu.edu
United States
 
NCT00659126
OHSU-2864, 5R01NS053468-02, 2864, SOL-06077-L
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
OHSU Knight Cancer Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP