Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.

Last updated: August 11, 2024
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Treatment

Assessment of the diagnostic value of Ferumoxytol for MR angiography.

Safety assessment of Ferumoxytol.

Clinical Study ID

NCT06551805
2023-178-05
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria: Patients aged 18 years and older with atherosclerosis.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Assessment of the diagnostic value of Ferumoxytol for MR angiography.
Phase:
Study Start date:
August 12, 2024
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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