A Phase 2 interventional study of Ferumoxytol and Gadolinium in Central Nervous System Neoplasm, Cranial Nerve Disorder and Metastatic Malignant Neoplasm in the Brain, sponsored by OHSU Knight Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by OHSU Knight Cancer Institute · Phase 2, Interventional, and Diagnostic
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.
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.
Subjects must have one of the following:
Exclusion Criteria:
Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.
Drug: Ferumoxytol · Drug: Gadolinium · Procedure: Magnetic Resonance Imaging
Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.
Drug: Ferumoxytol · Drug: Gadolinium · Procedure: Magnetic Resonance Imaging
Given IV
Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
Also known as: Gd
Undergo MRI
Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Visualization of normal vasculature
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).
Time frame: Up to 5 years
Visualization of abnormal vasculature
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).
Time frame: Up to 5 years
Visualization of normal anatomical structures
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).
Time frame: Up to 5 years
Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps
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).
Time frame: Up to 5 years
Contrast enhancement
The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).
Time frame: Up to 5 years
Border delineation
The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).
Time frame: Up to 5 years
Internal morphology
The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).
Time frame: Up to 5 years
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OHSU Knight Cancer Institute