Not Yet RecruitingPhase 2

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

China78 participantsStarted 2024-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements
✓. Age ≥18 years, no gender restrictions
✓. Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
✓. Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans

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
✕. Moderate to severe renal dysfunction, defined as aGFR \< 60 mL/min
✕. Contraindications to MRI, such as metallic implants or claustrophobia
✕. History of severe allergies, including drugs, contrast agents, or other allergens
✕. Severe liver disease or cardiovascular disease, or related abnormal test results
✕. Central nervous system inflammation or recent history of stroke
✕. Active infectious diseases, such as HIV, hepatitis B, or syphilis
✕. Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability

What they're measuring

Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)

Timeframe: 1 day procedure

Trial details

NCT IDNCT06731829

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04

Contact for this trial

Junpeng Zhuang

+0518-82342973 junpeng.zhuang.jz5@hengrui.com

View on ClinicalTrials.gov More For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions trials