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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
306
HRS-9231 injection.
Gadobutrol injection.
Magnetic Resonance Imaging (MRI).
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, 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 and size of lesions in MRI images after receiving HRS-9231.
Time frame: Day 1 after procedure.
Number and size of lesions in MRI images after receiving the control drug.
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.
Sensitivity for lesion detection on MRI images obtained with HRS-9231.
Time frame: Day 1 after procedure.
Specificity for lesion detection on MRI images obtained with HRS-9231.
Time frame: Day 1 after procedure.
Sensitivity for lesion detection on MRI images obtained with gadobutrol.
Time frame: Day 1 after procedure.
Specificity for lesion detection on MRI images obtained with gadobutrol.
Time frame: Day 1 after procedure.
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