Atherosclerosis
Conditions
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.
Interventions
DRUGSafety assessment of Ferumoxytol.
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.
DRUGAssessment of the diagnostic value of Ferumoxytol for MR angiography.
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| lower limb artery Image Acquisition | All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection. | atherosclerosis |
| Adverse Events | Before, during, after injection | no adverse events |
| Vital signs | Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan. | safety |
Countries
China
Contacts
Primary ContactJing Liang
Outcome results
None listed