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

Shanghai Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

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

Treatments: Device: Magnetic Resonance Imaging (MRI); Drug: Gadobutrol Injection; Drug: HRS-9231 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07275723

HRS-9231-302

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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306 participants in 2 patient groups

HRS-9231 + Gadobutrol Group

Experimental group

Description:

HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.

Treatment:

Drug: Gadobutrol Injection

Drug: HRS-9231 Injection

Device: Magnetic Resonance Imaging (MRI)

Gadobutrol + HRS-9231 Group

Experimental group

Description:

Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

Treatment:

Drug: Gadobutrol Injection

Drug: HRS-9231 Injection

Device: Magnetic Resonance Imaging (MRI)