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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
250
HRS-9231 injection.
Gadobutrol injection.
Magnetic Resonance Imaging (MRI).
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGTo compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.
Time frame: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.
Time frame: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.
Time frame: Day 1 after procedure.
HRS-9231 plasma concentration.
Time frame: Day 1 after procedure.
Population pharmacokinetic parameters - clearance.
Time frame: Day 1 after procedure.
Population pharmacokinetic parameters - apparent volume of distribution.
Time frame: Day 1 after procedure.
Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
Diagnostic confidence of MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
Technical adequacy of MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
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