Trials / Recruiting
RecruitingNCT03270059
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- OHSU Knight Cancer Institute · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferumoxytol | Given IV |
| DRUG | Gadolinium | Given IV |
| PROCEDURE | Magnetic Resonance Imaging | Undergo MRI |
Timeline
- Start date
- 2017-10-06
- Primary completion
- 2027-12-15
- Completion
- 2028-12-15
- First posted
- 2017-09-01
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03270059. Inclusion in this directory is not an endorsement.