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Clinical Trials in China / NCT06731829
Starting soon Phase 2

A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

NCT06731829 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 2
Started
2024-12
Last updated
2024-12-12

Condition(s) studied

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions

Investigational drug(s) / intervention(s)

HRS-9231Gadobutrol →

HRS-9231: HRS-9231

Gadobutrol: Gadobutrol

Study 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 explore the effective dose of HRS-9231 for CNS MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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, no gender restrictions 3. Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion 4. Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans 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. Moderate to severe renal dysfunction, defined as aGFR \< 60 mL/min 3. Contraindications to MRI, such as metallic implants or claustrophobia 4. History of severe allergies, including drugs, contrast agents, or other allergens 5. Severe liver disease or cardiovascular disease, or related abnormal test results 6. Central nervous system inflammation or recent history of stroke 7. Active infectious diseases, such as HIV, hepatitis B, or syphilis 8. Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability 9. Pregnancy, breastfeeding, or plans for conception, without effective contraception measures 10. Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents 11. Other conditions deemed unsuitable by the investigator

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
People's Hospital, Peking University Beijing Beijing Municipality

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06731829 on ClinicalTrials.gov ↗ ← All trials in China