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

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

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

NCT06731829•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

People's Hospital, Peking University

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 1, 2024

Primary Completion Date

April 1, 2025

Completion Date

April 1, 2025

Last Updated

December 12, 2024

Enrollment

ESTIMATED participants

Conditions

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

Interventions

HRS-9231

DRUG

Gadobutrol

DRUG

Contacts

Junpeng Zhuang

CONTACT

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