Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-29 @ 4:58 PM
Study NCT ID:
NCT03270059
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: