Clinical trial NCT06551805: Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
Official title: Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. CKD patients aged ≥18 years.
2. Presence of atherosclerosis in the head and neck vessels and/or coronary arteries and/or renal arteries, as indicated by other evidence.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ferumoxytol demonstrates a favorable safety profile in human subjects.
timeFrame: 2023.10-2026.12
measure: Ferumoxytol exhibits diagnostic efficacy for MR angiography.
timeFrame: 2023.10-2026.12
Secondary outcomes:
Other outcomes:
measure: lower limb artery Image Acquisition
timeFrame: All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection.
measure: Adverse Events
timeFrame: Before, during, after injection
measure: Vital signs
timeFrame: Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan.
Locations:
city: Nanjing
country: China
facility: Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
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