Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551805
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-06-30
Brief Title:
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis
Status:
RECRUITING
Status Verified Date:
2023-08
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:
We are preparing to initiate a clinical trial involving Ferumoxytol for magnetic resonance-enhanced imaging in patients with atherosclerosis The aim of this study is to assess the safety and effectiveness of Ferumoxytol for magnetic resonance angiography in patients with atherosclerosis
Detailed Description:
In this study the safety of Ferumoxytol as an MR imaging contrast agent will be assessed by monitoring vital signs and laboratory parameters such as complete blood count urinalysis and liver and kidney function tests before and after administration of Ferumoxytol Following the injection all patients will undergo two MRI scans at different time intervals ranging from 0 to 15 hours and from 24 to 48 hours Within one week prior to the injection patients will undergo standard laboratory tests as part of their routine clinical assessment and the pre-administration lab results will be documented
This study will prospectively enroll patients with atherosclerosis and Ferumoxytol-enhanced MRA imaging will be performed on all patients to investigate the diagnostic utility of Ferumoxytol as an MR imaging contrast agent
This study will prospectively enroll patients with atherosclerosis and Ferumoxytol-enhanced MRA imaging will be performed on all patients to investigate the diagnostic utility of Ferumoxytol as an MR imaging contrast agent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None