Status:
RECRUITING
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
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 effectiv...
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 ki...
Eligibility Criteria
Inclusion
- Inclusion criteria: Patients aged 18 years and older with atherosclerosis.
- Exclusion criteria:
- Individuals with a history of allergy or hypersensitivity to iron or dextran. Patients currently receiving oral or intravenous iron therapy. Patients with hemosiderosis or hemochromatosis. Patients with a history of allergic reactions to intravenous iron products or any iron overload-related conditions.
- Individuals who are unable to undergo magnetic resonance imaging (MRI) due to psychological reasons (such as claustrophobia) or physical reasons (such as the presence of non-compatible metallic objects in the body).
- Patients with end-stage diseases or life expectancy less than 1 year. Pregnant women. Any other individuals deemed unsuitable for inclusion by the investigator.
Exclusion
Key Trial Info
Start Date :
August 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06551805
Start Date
August 12 2024
End Date
December 30 2026
Last Update
August 13 2024
Active Locations (1)
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1
Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008