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Not yet recruitingNCT06731829Updated Dec 12, 2024

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

A Phase 2 interventional study of HRS-9231 and Gadobutrol in For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    HRS-9231 dose 1

    Drug: HRS-9231

  • Experimental
    HRS-9231 dose 2

    Drug: HRS-9231

  • Experimental
    HRS-9231 dose 3

    Drug: HRS-9231

  • Active comparator
    Gadobutrol

    Drug: Gadobutrol

Interventions

  • DrugHRS-9231

    HRS-9231

  • DrugGadobutrol

    Gadobutrol

06

What researchers measure

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

07

Study locations

1 site
  • People's Hospital, Peking University
    Peking, Beijing 100000, China
    • Nan Hong · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06731829
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Dec 12, 2024
Start date
Dec 2024 (estimated)
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Dec 12, 2024

Study contacts

Junpeng Zhuang
Contact
junpeng.zhuang.jz5@hengrui.com
+0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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