The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
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.
Arms & interventions
- DrugFerumoxytol
Given IV
- DrugGadolinium
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Outcome measures
Primary
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
Secondary
Contrast enhancement
Time frame: Up to 5 years
Border delineation
Time frame: Up to 5 years
Internal morphology
Time frame: Up to 5 years
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239