Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Central Nervous System Neoplasm
- Cranial Nerve Disorder
- Metastatic Malignant Neoplasm in the Brain
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 10 years and 125 years
- Gender
- Both males and females
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 enhan...
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 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. After completion of study, patients are followed up at 2 and 6 weeks.
Tracking Information
- NCT #
- NCT03270059
- Collaborators
- Celgene Corporation
- Oregon Health and Science University
- Investigators
- Principal Investigator: Prakash Ambady OHSU Knight Cancer Institute