150 Participants Needed

MRI with Gadolinium + Ferumoxytol for Brain Conditions

AE
LC
Overseen ByLisa C Muir, MPA:HA, CCRP
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: OHSU Knight Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research shows that using ferumoxytol as a contrast agent in MRI is generally safe, with no serious adverse events reported. Some mild to moderate reactions occurred in a small percentage of cases, but overall, it has a positive safety profile.36789

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

MF

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

I am at least 10 years old.
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
I have experienced neurological symptoms like headaches or seizures.
See 4 more

Exclusion Criteria

Subjects with three or more drug allergies from separate drug classes
I do not have severe brain symptoms like sudden pupil changes, quick muscle weakness, or fast drops in alertness.
I do not have genetic hemochromatosis or it has been ruled out with normal TS and SF tests.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gadolinium and ferumoxytol intravenously and undergo MRI over 60 minutes on day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

  • Ferumoxytol
  • Gadolinium
  • Magnetic Resonance Imaging
Trial OverviewThe study is testing how well two types of MRI contrast agents—gadolinium and ferumoxytol—work in diagnosing central nervous system problems. It aims to improve detection and diagnosis of brain-related health issues by comparing the effectiveness of these imaging techniques.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group II (ferumoxytol, gadolinium, MRI)Experimental Treatment3 Interventions
Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.
Group II: Group I (gadolinium, ferumoxytol, MRI)Experimental Treatment3 Interventions
Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

Magnetic Resonance Imaging is already approved in United States for the following indications:

🇺🇸
Approved in United States as Lumakras (sotorasib) for:
  • Non-small cell lung cancer with KRAS G12C mutation
🇺🇸
Approved in United States as Vectibix (panitumumab) for:
  • 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

Trials
239
Recruited
2,089,000+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Celgene Corporation

Industry Sponsor

Trials
446
Recruited
58,500+
Mark Alles profile image

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer profile image

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Findings from Research

Ferumoxytol, an iron oxide nanoparticle, provides enhanced imaging of malignant brain tumors, peaking in contrast enhancement 24 to 28 hours after injection, making it effective for dynamic MRI assessments.
Unlike gadolinium, which leaks from blood vessels early, ferumoxytol remains intravascular during the initial phase, improving the accuracy of tumor perfusion evaluations across various magnetic field strengths.
The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study.Neuwelt, EA., Várallyay, CG., Manninger, S., et al.[2022]
Ferumoxytol-enhanced MRI is as effective as gadolinium-enhanced MRI for detecting intracranial metastatic disease, based on a study of 19 patients with various types of cancer.
The study found no significant differences in the number or size of metastatic lesions detected by either imaging method, suggesting that ferumoxytol could be a safe alternative when gadolinium is contraindicated.
Ferumoxytol-Enhanced MRI Is Not Inferior to Gadolinium-Enhanced MRI in Detecting Intracranial Metastatic Disease and Metastasis Size.Hamilton, BE., Barajas, R., Nesbit, GM., et al.[2021]
Ferumoxytol, an FDA-approved iron supplement, shows promise as a safer alternative to gadolinium-based contrast agents for MRI, particularly in children, as it does not deposit in the brain and can be metabolized.
Studies indicate that ferumoxytol provides significant signal enhancement in MRI, making it a potentially effective option for improving diagnostic accuracy in pediatric imaging compared to traditional gadolinium chelates.
How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol.Daldrup-Link, HE., Theruvath, AJ., Rashidi, A., et al.[2022]

References

The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study. [2022]
Ferumoxytol-Enhanced MRI Is Not Inferior to Gadolinium-Enhanced MRI in Detecting Intracranial Metastatic Disease and Metastasis Size. [2021]
How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol. [2022]
Ferumoxytol-Enhanced MRI in Children and Young Adults: State of the Art. [2023]
Comparative analysis of ferumoxytol and gadoteridol enhancement using T1- and T2-weighted MRI in neuroimaging. [2021]
Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults. [2018]
Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. [2023]
Relaxivity of Ferumoxytol at 1.5 T and 3.0 T. [2020]
Hemodynamic safety and efficacy of ferumoxytol as an intravenous contrast agents in pediatric patients and young adults. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Pictorial review on abdominal applications of ferumoxytol in MR imaging. [2020]