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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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