Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
- Conditions
- Atherosclerosis
- Interventions
- Drug: Safety assessment of Ferumoxytol.Drug: Assessment of the diagnostic value of Ferumoxytol for MR angiography.
- Registration Number
- NCT06551805
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Safety assessment and the diagnostic value of Ferumoxytol. Assessment of the diagnostic value of Ferumoxytol for MR angiography. Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection Safety assessment and the diagnostic value of Ferumoxytol. Safety assessment of Ferumoxytol. Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection
- Primary Outcome Measures
Name Time Method Ferumoxytol demonstrates a favorable safety profile in human subjects. 2023.10-2026.12 safe
Ferumoxytol exhibits diagnostic efficacy for MR angiography. 2023.10-2026.12 diagnostic efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
🇨🇳Nanjing, Jiangsu, China