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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Brain Neoplasms
Drug: Ferumoxytol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3 Tesla (T) and 7 Tesla (T) in Patients With Malignant Brain Tumors Either Before or After Therapy

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • The primary objective of this project is to compare quantitative imaging measures of brain tumor vascularity obtained from 3 Tesla (T) and 7 Tesla (T) MRI instruments [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 112
Study Start Date: November 2006
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
MR imaging at 3 Tesla (T)
Drug: Ferumoxytol
4mg/kg
Other Name: Ferumoxytol
Active Comparator: 2
MR imaging at 7 Tesla (T)
Drug: Ferumoxytol
4mg/kg
Other Name: Ferumoxytol

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659126

Contacts
Contact: Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu
Contact: Cynthia A Lacy, BSN 503-494-5626 lacyc@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Edward A Neuwelt, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00659126     History of Changes
Other Study ID Numbers: OHSU-2864, 5R01NS053468-02, 2864, SOL-06077-L
Study First Received: April 10, 2008
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
ferumoxytol
Diagnostic imaging

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 21, 2014