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The purpose of this study is to evaluate the efficacy of HRS-9231 for Magnetic Resonance Imaging (MRI) of body regions excluding the Central Nervous System (CNS) in patients undergoing MRI examinations, using the patient's own unenhanced MRI images as a control; to demonstrate that the efficacy of HRS-9231 is not inferior to gadobutrol for lesion visualization in body MRI; to evaluate the safety of HRS-9231 for body MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in subjects undergoing body MRI examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9231 + Gadobutrol Group | Experimental | HRS-9231 enhanced MRI then Gadobutrol enhanced MRI. |
|
| Gadobutrol + HRS-9231 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 and size of 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 |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China | ||
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| Gadobutrol Injection | Drug | Gadobutrol injection. |
|
| Magnetic Resonance Imaging (MRI) | Device | Magnetic Resonance Imaging (MRI). |
|
| Number and size of lesions in MRI images after receiving the control drug. | 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. |
| Sensitivity for lesion detection on MRI images obtained with HRS-9231. | Day 1 after procedure. |
| Specificity for lesion detection on MRI images obtained with HRS-9231. | Day 1 after procedure. |
| Sensitivity for lesion detection on MRI images obtained with gadobutrol. | Day 1 after procedure. |
| Specificity for lesion detection on MRI images obtained with gadobutrol. | Day 1 after procedure. |
| West China Hospital of Sichuan University |
| Chengdu |
| Sichuan |
| 610041 |
| 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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