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The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol + HRS-9231 Group | Experimental | HRS-9231 enhanced MRI then Gadobutrol enhanced MRI. |
|
| HRS-9231 + Gadobutrol Group | Experimental | Gadobutrol enhanced MRI then HRS-9231 enhanced MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9231 Injection | Drug | HRS-9231 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI. | Day 1 after procedure. | |
| To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI. | Day 1 after procedure. | |
| To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI. | Day 1 after procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI. | Day 1 after procedure. | |
| Number, size, and location of CNS lesions in MRI images after receiving HRS-9231. | Day 1 after procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Henan Provincial People's Hospital |
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| Gadobutrol Injection | Drug | Gadobutrol injection. |
|
| Magnetic Resonance Imaging (MRI) | Device | Magnetic Resonance Imaging (MRI). |
|
| Number, size, and location of CNS lesions in MRI images after receiving gadobutrol. | Day 1 after procedure. |
| HRS-9231 plasma concentration. | Day 1 after procedure. |
| Population pharmacokinetic parameters - clearance. | Day 1 after procedure. |
| Population pharmacokinetic parameters - apparent volume of distribution. | Day 1 after procedure. |
| Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol. | Day 1 after procedure. |
| Diagnostic confidence of MRI images of HRS-9231 and gadobutrol. | Day 1 after procedure. |
| Technical adequacy of MRI images of HRS-9231 and gadobutrol. | Day 1 after procedure. |
| Zhengzhou |
| Henan |
| 450003 |
| China |
| ID | Term |
|---|---|
| C090600 | gadobutrol |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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