Actively Recruiting
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions
Led by Shanghai Shengdi Pharmaceutical Co., Ltd · Updated on 2026-04-21
250
Participants Needed
2
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow study requirements
- Age 18 years or older, male or female
- Have at least one known or suspected CNS lesion or abnormality detected by imaging in the past 12 months
You will not qualify if you...
- Clinically unstable or severe diseases affecting study results or imaging reliability
- Severe renal impairment with aGFR less than 30 mL/min/1.73 m2
- Acute kidney injury regardless of eGFR
- Contraindications to MRI or Gadobutrol, such as metal implants, pacemakers, or claustrophobia
- History of severe allergies including drugs or contrast agents
- Severe cardiovascular disease
- Pregnant or breastfeeding women
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
F
Fei Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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