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This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyglucose superparamagnetic iron oxide injection 2.5 mg/kg | Experimental | Intravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose; |
|
| polyglucose superparamagnetic iron oxide injection 3.0 mg/kg | Experimental | Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysaccharide superparamagnetic iron oxide injection | Drug | Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-enhanced magnetic resonance angiography (CE-MRA) | CE-MRA of the whole heart and large arteries, coronary angiography and contrast-enhanced scan of the upper abdomen, the aorta and its main branches (left and right renal arteries, celiac trunk, superior mesenteric arteries, bilateral iliac arteries) as well as bilateral femoral arteries of the lower limbs will be evaluated | Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinxiang Central Hospital | Xinxiang | Henan | 453000 | China |
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