Ferumoxytol and Gadolinium Magnetic Resonance Imaging (MRI) at 3T and 7T in Patients With Malignant Brain Tumors
This study is currently recruiting participants.
Verified March 2013 by OHSU Knight Cancer Institute
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00659126
First received: April 10, 2008
Last updated: March 26, 2013
Last verified: March 2013
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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 3T and 7T 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 T and 7T 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: | December 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
MR imaging at 3T
|
Drug: Ferumoxytol
4mg/kg
Other Name: Ferumoxytol
|
|
Active Comparator: 2
MR imaging at 7T
|
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 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).
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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659126
Contacts
| Contact: Edward A Neuwelt, MD | 503-494-5626 | neuwelte@ohsu.edu |
| Contact: Nancy A Hedrick, BA | 503-494-5626 | hedrickn@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: | March 26, 2013 |
| 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 Ferumoxytol Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013