Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-13 @ 2:03 PM
Study NCT ID:
NCT06551805
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2023-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
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:
False
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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: