NCT07275723

Brief Summary

The purpose of this study is to evaluate the efficacy of HRS-9231 for Magnetic Resonance Imaging (MRI) of body regions excluding the Central Nervous System (CNS) in patients undergoing MRI examinations, using the patient's own unenhanced MRI images as a control; to demonstrate that the efficacy of HRS-9231 is not inferior to gadobutrol for lesion visualization in body MRI; to evaluate the safety of HRS-9231 for body MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in subjects undergoing body MRI examinations.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
306

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 14, 2025

Completed
4 days 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

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

January 7, 2026

Conditions

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)

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 (10)

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

    Day 1 after procedure.

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

    Day 1 after procedure.

  • Number and size of lesions in MRI images after receiving the control drug.

    Day 1 after procedure.

  • HRS-9231 plasma concentration.

    Day 1 after procedure.

  • Population pharmacokinetic parameters - clearance.

    Day 1 after procedure.

  • +5 more secondary outcomes

Study Arms (2)

HRS-9231 + Gadobutrol Group

EXPERIMENTAL

HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.

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

Gadobutrol + HRS-9231 Group

EXPERIMENTAL

Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

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

Interventions

HRS-9231 InjectionDRUG

HRS-9231 injection.

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

Gadobutrol 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:

  • Provide written informed consent, be willing and able to comply with study requirements.
  • Age ≥18 years, male or female.
  • Subjects who are scheduled to undergo a contrast-enhanced MRI (including MRA) examination and who, within 12 months prior to signing the informed consent form, have had imaging examinations that identified at least one known or highly suspected region of enhancement abnormality or lesion in the body.

You may not qualify if:

  • Investigator judges unstable clinical condition or comorbidities that may affect MRI image comparability or study parameters.
  • Severe renal impairment (baseline eGFR \< 30 mL/min/1.73m²) before first dose; acute kidney injury regardless of eGFR.
  • Acute kidney injury, irrespective of eGFR levels.
  • Contraindication to MRI or gadolinium contrast agents.
  • History of severe allergic reactions to drugs, contrast agents, or other allergens.
  • Severe cardiovascular disease.
  • Pregnant or breastfeeding women.
  • Any other condition deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

gadobutrolMagnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Xiao Chen

CONTACT

+86-021-61941333xiao.chen.xc1@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 14, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

CN(2)