Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
Overview
- Phase
- Not Applicable
- Intervention
- Safety assessment of Ferumoxytol.
- Conditions
- Atherosclerosis
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Ferumoxytol demonstrates a favorable safety profile in human subjects.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Safety assessment and the diagnostic value of Ferumoxytol.
Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection
Intervention: Safety assessment of Ferumoxytol.
Safety assessment and the diagnostic value of Ferumoxytol.
Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection
Intervention: Assessment of the diagnostic value of Ferumoxytol for MR angiography.
Outcomes
Primary Outcomes
Ferumoxytol demonstrates a favorable safety profile in human subjects.
Time Frame: 2023.10-2026.12
safe
Ferumoxytol exhibits diagnostic efficacy for MR angiography.
Time Frame: 2023.10-2026.12
diagnostic efficacy