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Completed

NCT Number: NCT07275723

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS-9231 Injection

Drug

HRS-9231 injection.

Gadobutrol Injection

Drug

Gadobutrol injection.

Magnetic Resonance Imaging (MRI)

Device

Magnetic Resonance Imaging (MRI).

Primary outcomes

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

    Time frame: Day 1 after procedure.

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

    Time frame: Day 1 after procedure.

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

    Time frame: Day 1 after procedure.

Secondary outcomes

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

    Time frame: Day 1 after procedure.

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

    Time frame: Day 1 after procedure.

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

    Time frame: Day 1 after procedure.

  4. HRS-9231 plasma concentration.

    Time frame: Day 1 after procedure.

  5. Population pharmacokinetic parameters - clearance.

    Time frame: Day 1 after procedure.

  6. Population pharmacokinetic parameters - apparent volume of distribution.

    Time frame: Day 1 after procedure.

  7. Sensitivity for lesion detection on MRI images obtained with HRS-9231.

    Time frame: Day 1 after procedure.

  8. Specificity for lesion detection on MRI images obtained with HRS-9231.

    Time frame: Day 1 after procedure.

  9. Sensitivity for lesion detection on MRI images obtained with gadobutrol.

    Time frame: Day 1 after procedure.

  10. Specificity for lesion detection on MRI images obtained with gadobutrol.

    Time frame: Day 1 after procedure.

Sponsors and collaborators

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Jun 30, 2026

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.