MRI with Gadolinium + Ferumoxytol for Brain Conditions
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have allergies to certain drugs or have received ferumoxytol recently, you may not be eligible to participate.
What data supports the effectiveness of the drug Ferumoxytol in MRI for brain conditions?
Research shows that Ferumoxytol-enhanced MRI is as effective as gadolinium-enhanced MRI in detecting brain metastases, and it may be a safer alternative for patients who cannot use gadolinium. Ferumoxytol is biodegradable and does not stay in the brain long-term, making it a promising option for MRI imaging, especially in children.12345
Is MRI with Ferumoxytol and Gadolinium safe for humans?
How does the treatment using MRI with Gadolinium and Ferumoxytol differ from other treatments for brain conditions?
This treatment is unique because it uses ferumoxytol, an iron oxide nanoparticle, as an alternative to gadolinium for MRI contrast, which is beneficial for patients who cannot use gadolinium due to safety concerns. Ferumoxytol provides prolonged imaging signals and is not deposited in the brain, making it a safer option for certain patients, including children.123510
Research Team
Michael F Regner, MD
Principal Investigator
OHSU Knight Cancer Institute
Eligibility Criteria
This trial is for individuals with brain abnormalities (tumors or other issues) who have neurological symptoms like headaches or seizures. They must be over 10 years old, able to undergo MRI without anesthesia, and not pregnant. Women of childbearing age should use contraception. Participants can't join if they have severe brain swelling signs, are pregnant/lactating, have iron overload conditions, recent ferumoxytol use, multiple drug allergies, or certain metal implants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gadolinium and ferumoxytol intravenously and undergo MRI over 60 minutes on day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ferumoxytol
- Gadolinium
- Magnetic Resonance Imaging
Magnetic Resonance Imaging is already approved in United States for the following indications:
- Non-small cell lung cancer with KRAS G12C mutation
- Advanced colorectal cancer that is wild-type RAS
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Oregon Health and Science University
Collaborator
Celgene Corporation
Industry Sponsor
Mark Alles
Celgene Corporation
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Sol J. Barer
Celgene Corporation
Chief Medical Officer since 2006
PhD in Organic and Physical Chemistry from Rutgers University