A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions

June 29, 2026 updated by: Shanghai Shengdi Pharmaceutical Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provide written informed consent, be willing and able to comply with study requirements.
  2. Age ≥18 years, male or female.
  3. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-9231 + Gadobutrol Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
Drug: HRS-9231 Injection
HRS-9231 injection.
Drug: Gadobutrol Injection
Gadobutrol injection.
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI).
Experimental: Gadobutrol + HRS-9231 Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
Drug: HRS-9231 Injection
HRS-9231 injection.
Drug: Gadobutrol Injection
Gadobutrol injection.
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time Frame: Day 1 after procedure.
Day 1 after procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
HRS-9231 plasma concentration.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Population pharmacokinetic parameters - clearance.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Population pharmacokinetic parameters - apparent volume of distribution.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Number and size of lesions in MRI images after receiving HRS-9231.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Number and size of lesions in MRI images after receiving the control drug.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Sensitivity for lesion detection on MRI images obtained with HRS-9231.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Specificity for lesion detection on MRI images obtained with HRS-9231.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Sensitivity for lesion detection on MRI images obtained with gadobutrol.
Time Frame: Day 1 after procedure.
Day 1 after procedure.
Specificity for lesion detection on MRI images obtained with gadobutrol.
Time Frame: Day 1 after procedure.
Day 1 after procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Actual)

April 18, 2026

Study Completion (Actual)

June 9, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-9231-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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