Back to search results

Gadolinium and Ferumoxytol MRI for Central Nervous System Abnormalities

This study is looking at how well two different contrast agents, Gadolinium and Ferumoxytol, work with Magnetic Resonance Imaging (MRI) to help doctors see and diagnose problems in the brain and spinal cord (central nervous system). You might be able to join if you have neurological symptoms like headaches or seizures, have unusual findings on a brain scan, or have cancer elsewhere in your body that could affect your brain. The study aims to see how well these agents help visualize normal and abnormal blood vessels and structures in the brain over a period of up to five years. The study is currently unclear on its recruitment status.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 150 participants who will be randomly assigned to one of two groups.
What's involved
You would receive Gadolinium and Ferumoxytol intravenously (through an IV) and undergo an MRI scan over 60 minutes on one day.
Compensation
Not stated in the trial record.
Follow-up
The study will track how well the imaging works for up to five years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03270059

Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

Recruiting
PHASE2Ages 10+InterventionalDiagnostic
OHSU Knight Cancer Institute
~150 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:FerumoxytolGadoliniumMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visualization of normal vasculature
Measured over Up to 5 years
+3 more outcomes measured

Conditions

Central Nervous System Neoplasm
Cranial Nerve Disorder
Metastatic Malignant Neoplasm in the Brain

Explore related trials

Central Nervous System NeoplasmCranial Nerve DisorderMalignant Brain Neoplasm

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Michael F Regner, MD · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Amy E Huddleston, MPA:HA, CCRP
[email protected]
5034942910
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Subjects must have one of the following:
Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)
Subjects must be able to undergo MRI imaging without anesthesia
Subjects must be at least 10 years of age
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
Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal \< 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion

Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
Subjects who are pregnant or lactating or who suspect they might be pregnant
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
Subject who have received ferumoxytol within 3 weeks of study entry
Subjects with three or more drug allergies from separate drug classes

What this trial measures

  • Visualization of normal vasculatureUp to 5 years

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% confidence interval (CI) between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  • Visualization of abnormal vasculatureUp to 5 years

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  • Visualization of normal anatomical structuresUp to 5 years

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  • Identification of the lesion corresponding areas on cerebral blood volume (CBV) mapsUp to 5 years

    Will assess the confidence in identifying the lesion corresponding areas on CBV maps as well as signal change (deltaR2\*) and relative cerebral blood volume. Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).