NCT Number: NCT06551805
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
Bing Zhang, MD, PhD
CONTACT
Bing Zhang, MD, PhD
PRINCIPAL_INVESTIGATOR
Wen Zhang, MD, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Observe the injection site for skin invagination, rash, or urticaria during injection. Patients and their relatives were asked about any subjective adverse events before, during, and after drug injection, and all adverse events were recorded on the case report forms, and adverse events were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) from Grade 1 "mild" to Grade 5 "death", Observe the vital signs of patients. Patients undergoing MRI underwent electrocardiogram (ECG) monitoring before and within 60 minutes after ferumoxytol administration, specifically including: biochemical panel, iron metabolism, liver and kidney function, cytokines, blood routine, urine routine, 24-hour urine volume, glycosylated hemoglobin and so on. All patients received a total of 3 blood and urine collections at 7 days before injection, 48 hours after injection, 1month to 3months after injection.
Other names: Superparamagnetic iron oxide
steady-state, high-spatial-resolution, three-dimensional fast low-angle shot acquisition technique, T2W-MDIR imaging, polysaccharide superparamagnetic iron oxide injection enhanced T1W and T2W, T2* mapping, and Steady state free precession sequence, T2 weighted black blood sequence, T2 preparation single shot steady state free precession sequence, T2* weighted multi-echo/gradient echo sequence, polysaccharide superparamagnetic iron oxide injection enhanced imaging, Breath-triggered Transverse 3D Balance-Vortex Field Echo (b-TFE) Magnetic Resonance Angiography, iMSDE-SPGR Sequence, 4D Flow MRI. the MRI anxiety questionnaire.
Other names: Superparamagnetic iron oxide
Time frame: 2023.10-2026.12
safe
Time frame: 2023.10-2026.12
diagnostic efficacy
Time frame: All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection.
atherosclerosis
Time frame: Before, during, after injection
no adverse events
Time frame: Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan.
safety
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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