A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
- •Age ≥ 18 years, male or female.
- •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
- •Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters.
- •Severe renal impairment, defined as aGFR \< 30 mL/min/1.73 m
- •Acute kidney injury, irrespective of eGFR levels.
- •Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia.
- •History of severe allergies, including drugs, contrast agents, or other allergens.
- •Severe cardiovascular disease.
- •Female subjects who are pregnant or breastfeeding.
- •Other conditions deemed unsuitable by the investigator.
Arms & Interventions
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
Intervention: Gadobutrol Injection (Drug)
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
Intervention: HRS-9231 Injection (Drug)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
Intervention: HRS-9231 Injection (Drug)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
Intervention: Magnetic Resonance Imaging (MRI) (Device)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
Intervention: Gadobutrol Injection (Drug)
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
Intervention: Magnetic Resonance Imaging (MRI) (Device)
Outcomes
Primary Outcomes
To 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.
Secondary Outcomes
- HRS-9231 plasma concentration.(Day 1 after procedure.)
- Population pharmacokinetic parameters - clearance.(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.)
- Population pharmacokinetic parameters - apparent volume of distribution.(Day 1 after procedure.)
- To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.(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.)