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Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

NCT03270059•OHSU Knight Cancer Institute

View on ClinicalTrials.gov

Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol. II. To test signal changes of T2\*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection. SECONDARY OBJECTIVES: I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths. EXPLORATORY OBJECTIVES: I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various brain pathologies. II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head \& neck, and liver lesions OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Key Dates

Start Date

October 6, 2017

Primary Completion Date

December 15, 2027

Completion Date

December 15, 2028

Last Updated

February 27, 2026

Enrollment

150

ESTIMATED participants

Conditions

Central Nervous System NeoplasmCranial Nerve DisorderMetastatic Malignant Neoplasm in the Brain

Interventions

Ferumoxytol

DRUG

Gadolinium

DRUG

Magnetic Resonance Imaging

PROCEDURE

Contacts

Amy E Huddleston, MPA:HA, CCRP

CONTACT

5034942910 huddlesa@ohsu.edu

Lisa C Muir, MPA:HA, CCRP

CONTACT

5034942910 bennetli@ohsu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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