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Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) for Brain Metastasis

Phase 2
Waitlist Available
Led By Edward Neuwelt
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 2
Awards & highlights

Summary

This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. The contrast imaging agent ferumoxytol consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.

Eligible Conditions
  • Brain Metastasis
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CNR, in Terms of Normalized Signal Intensity Changes, for Dynamic Susceptibility Contrast (DSC) MRI Data Sets at 3T and 7T (Gadolinium and Ferumoxytol)
Contrast to Noise Ratio (CNR), in Terms of Normalized Signal Intensity Changes, for T1-weighted MRI Signal at 3T and 7T (Gadolinium [Gd] T1-weighted Magnetic Resonance Imaging [MRI] DCE Data Only)
Secondary study objectives
Change in Cerebral Blood Volume (CBV) Measurements, Quantified Using DSC Techniques
Change in Tumor Microvascularity on Susceptibility-weighted Images (SWI) Before and After Ferumoxytol
Presence of Iron Staining
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (Gd, ferumoxytol, 3T or 7T MRI)Experimental Treatment7 Interventions
Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3 Tesla Magnetic Resonance Imaging
2004
N/A
~160
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
2006
Completed Phase 2
~310
Gadolinium
2006
Completed Phase 4
~620
Ferumoxytol
2011
Completed Phase 4
~4380
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
2006
Completed Early Phase 1
~220

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,587 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,849 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,908 Total Patients Enrolled
~2 spots leftby Sep 2025