For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)Phase 3NCT07275723

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

A Phase 3 study testing HRS-9231 Injection, Gadobutrol Injection and Magnetic Resonance Imaging (MRI) in people with For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS), run by Shanghai Shengdi Pharmaceutical Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)
What is being tested?: HRS-9231 Injection, Gadobutrol Injection and Magnetic Resonance Imaging (MRI)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 309 participants
Where: 2 sitesChina
Study dates: 14 Nov 2025to 9 Jun 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

Other trials in China

About this study

Official 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)

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.

Conditions: For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)
Being tested: HRS-9231 Injection, Gadobutrol Injection, Magnetic Resonance Imaging (MRI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-9231 InjectionDrug
HRS-9231 injection.
Gadobutrol InjectionDrug
Gadobutrol injection.
Magnetic Resonance Imaging (MRI)Device
Magnetic Resonance Imaging (MRI).

Study groups in NCT07275723
Study group	Role	What they receive
HRS-9231 + Gadobutrol Group	Experimental	HRS-9231 enhanced MRI then Gadobutrol enhanced MRI. Receives: Drug: HRS-9231 Injection; Drug: Gadobutrol Injection; Device: Magnetic Resonance Imaging (MRI)
Gadobutrol + HRS-9231 Group	Experimental	Gadobutrol enhanced MRI then HRS-9231 enhanced MRI. Receives: Drug: HRS-9231 Injection; Drug: Gadobutrol Injection; Device: Magnetic Resonance Imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 20259 Jun 2026

First posted10 Dec 2025
Study start14 Nov 2025
Primary completion18 Apr 2026
Study completion9 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07275723
Sponsor's protocol ID: HRS-9231-302
Status last verified: Jun 2026
First submitted: 18 Nov 2025
Last updated: 30 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT07275723
Acronym / sponsor ID: HRS-9231-302
Conditions: For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 14 Nov 2025 (actual)
Primary completion: 18 Apr 2026 (actual)
Study completion: 9 Jun 2026 (actual)
First posted: 10 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HRS-9231 + Gadobutrol Group	Experimental	Drug: HRS-9231 Injection, Drug: Gadobutrol Injection, Device: Magnetic Resonance Imaging (MRI)HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
Gadobutrol + HRS-9231 Group	Experimental	Drug: HRS-9231 Injection, Drug: Gadobutrol Injection, Device: Magnetic Resonance Imaging (MRI)Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-9231 InjectionHRS-9231 injection.	Drug	Gadobutrol + HRS-9231 Group, HRS-9231 + Gadobutrol Group
Gadobutrol InjectionGadobutrol injection.	Drug	Gadobutrol + HRS-9231 Group, HRS-9231 + Gadobutrol Group
Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI).	Device	Gadobutrol + HRS-9231 Group, HRS-9231 + Gadobutrol Group

Primary outcome

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

10 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI. (time frame: Day 1 after procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07275723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.