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NCT Number: NCT06731829

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

People's Hospital, Peking University

Beijing, Beijing Municipality, 100000, China

Location contact

Nan Hong

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy, breastfeeding, or plans for conception, without effective contraception measures
  • Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents
  • Other conditions deemed unsuitable by the investigator

Treatment and study plan

HRS-9231

Drug

HRS-9231

Gadobutrol

Drug

Gadobutrol

Primary outcomes

  1. 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)

    Time frame: 1 day procedure

Secondary outcomes

  1. Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).

    Time frame: 1 day procedure

  2. Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.

    Time frame: 1 day procedure

  3. Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.

    Time frame: 1 day procedure

  4. HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).

    Time frame: 1 day procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Junpeng Zhuang

CONTACT

[email protected]

+0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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