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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-14

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HRS-9231 + Gadobutrol Group

HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.

Group Type EXPERIMENTAL

HRS-9231 Injection

Intervention Type DRUG

HRS-9231 injection.

Gadobutrol Injection

Intervention Type DRUG

Gadobutrol injection.

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI).

Gadobutrol + HRS-9231 Group

Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

Group Type EXPERIMENTAL

HRS-9231 Injection

Intervention Type DRUG

HRS-9231 injection.

Gadobutrol Injection

Intervention Type DRUG

Gadobutrol injection.

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI).

Interventions

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HRS-9231 Injection

HRS-9231 injection.

Intervention Type DRUG

Gadobutrol Injection

Gadobutrol injection.

Intervention Type DRUG

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No