NCT07275814

Brief 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 demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

April 16, 2026

Conditions

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

Outcome Measures

Primary Outcomes (3)

  • To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.

    Day 1 after procedure.

  • To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.

    Day 1 after procedure.

  • To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.

    Day 1 after procedure.

Secondary Outcomes (9)

  • To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.

    Day 1 after procedure.

  • Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.

    Day 1 after procedure.

  • Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.

    Day 1 after procedure.

  • HRS-9231 plasma concentration.

    Day 1 after procedure.

  • Population pharmacokinetic parameters - clearance.

    Day 1 after procedure.

  • +4 more secondary outcomes

Study Arms (2)

Gadobutrol + HRS-9231 Group

EXPERIMENTAL

HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.

Drug: HRS-9231 InjectionDrug: Gadobutrol InjectionDevice: Magnetic Resonance Imaging (MRI)

HRS-9231 + Gadobutrol Group

EXPERIMENTAL

Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

Drug: HRS-9231 InjectionDrug: Gadobutrol InjectionDevice: Magnetic Resonance Imaging (MRI)

Interventions

Gadobutrol InjectionDRUG

Gadobutrol injection.

Gadobutrol + HRS-9231 GroupHRS-9231 + Gadobutrol Group
HRS-9231 InjectionDRUG

HRS-9231 injection.

Gadobutrol + HRS-9231 GroupHRS-9231 + Gadobutrol Group
Magnetic Resonance Imaging (MRI)DEVICE

Magnetic Resonance Imaging (MRI).

Gadobutrol + HRS-9231 GroupHRS-9231 + Gadobutrol Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
  • Age ≥ 18 years, male or female.
  • Have at least one known or highly suspected CNS enhancement abnormality or lesion detected by imaging (e.g., CT and MRI) within 12 months prior to ICF signing.

You may not qualify if:

  • Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters.
  • Severe renal impairment, defined as aGFR \< 30 mL/min/1.73 m2.
  • Acute kidney injury, irrespective of eGFR levels.
  • Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia.
  • History of severe allergies, including drugs, contrast agents, or other allergens.
  • Severe cardiovascular disease.
  • Female subjects who are pregnant or breastfeeding.
  • Other conditions deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Interventions

gadobutrolMagnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Fei Shi

CONTACT

+86-021-61600276fei.shi@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 10, 2025

Study Start

November 17, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CN(2)