For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
Conditions
Brief summary
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.
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. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements. 2. Age ≥ 18 years, male or female. 3. Have at least one known or highly suspected CNS enhancement abnormality or lesion detected by imaging (e.g., CT and MRI) within 12 months prior to ICF signing.
Exclusion criteria
1. Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters. 2. Severe renal impairment, defined as aGFR \< 30 mL/min/1.73 m2. 3. Acute kidney injury, irrespective of eGFR levels. 4. Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia. 5. History of severe allergies, including drugs, contrast agents, or other allergens. 6. Severe cardiovascular disease. 7. Female subjects who are pregnant or breastfeeding. 8. Other conditions 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, size, and location of CNS lesions in MRI images after receiving HRS-9231. | Day 1 after procedure. |
| 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. |
Countries
China
Outcome results
None listed