For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)
Conditions
Brief summary
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.
Interventions
HRS-9231 injection.
Gadobutrol injection.
DEVICEMagnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI).
Sponsors
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent, be willing and able to comply with study requirements. 2. Age ≥18 years, male or female. 3. Subjects who are scheduled to undergo a contrast-enhanced MRI (including MRA) examination and who, within 12 months prior to signing the informed consent form, have had imaging examinations that identified at least one known or highly suspected region of enhancement abnormality or lesion in the body.
Exclusion criteria
1. Investigator judges unstable clinical condition or comorbidities that may affect MRI image comparability or study parameters. 2. Severe renal impairment (baseline eGFR \< 30 mL/min/1.73m²) before first dose; acute kidney injury regardless of eGFR. 3. Acute kidney injury, irrespective of eGFR levels. 4. Contraindication to MRI or gadolinium contrast agents. 5. History of severe allergic reactions to drugs, contrast agents, or other allergens. 6. Severe cardiovascular disease. 7. Pregnant or breastfeeding women. 8. Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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. |
| 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. |
Countries
China
Outcome results
None listed