For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) LesionsPhase 3NCT07275814
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) 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 Central Nervous System (CNS) Lesions, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
- 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
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 17 Nov 2025to 17 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
- Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
- Age ≥ 18 years, male or female.
- Have at least one known or highly suspected CNS enhancement abnormality or lesion detected by imaging (e.g., CT and MRI) within 12 months prior to ICF signing.
Who cannot join
- Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters.
- Severe renal impairment, defined as aGFR < 30 mL/min/1.73 m2.
- Acute kidney injury, irrespective of eGFR levels.
- Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia.
- History of severe allergies, including drugs, contrast agents, or other allergens.
- Severe cardiovascular disease.
- Female subjects who are pregnant or breastfeeding.
- Other conditions deemed unsuitable by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
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 Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.
- Conditions
- For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
- 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 group | Role | What they receive |
|---|---|---|
| Gadobutrol + HRS-9231 Group | Experimental | HRS-9231 enhanced MRI then Gadobutrol enhanced MRI. Receives: Drug: HRS-9231 Injection; Drug: Gadobutrol Injection; Device: Magnetic Resonance Imaging (MRI) |
| HRS-9231 + Gadobutrol 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 (9)
To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.
Measured: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.
Measured: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.
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.
Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol.
Measured: Day 1 after procedure.
Diagnostic confidence of MRI images of HRS-9231 and gadobutrol.
Measured: Day 1 after procedure.
Technical adequacy of MRI images of HRS-9231 and 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.
- First posted10 Dec 2025
- Study start17 Nov 2025
- Primary completion17 Jun 2026
- Study completion17 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 Central Nervous System (CNS) LesionsStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275814
- Sponsor's protocol ID
- HRS-9231-301
- 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 Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT07275814
- Acronym / sponsor ID
- HRS-9231-301
- Conditions
- For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 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.
The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol + HRS-9231 Group | Experimental | Drug: HRS-9231 Injection, Drug: Gadobutrol Injection, Device: Magnetic Resonance Imaging (MRI)HRS-9231 enhanced MRI then Gadobutrol enhanced MRI. |
| HRS-9231 + Gadobutrol 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)
- Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
- Age ≥ 18 years, male or female.
- Have at least one known or highly suspected CNS enhancement abnormality or lesion detected by imaging (e.g., CT and MRI) within 12 months prior to ICF signing.
Key exclusion criteria (8 listed)
- Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters.
- Severe renal impairment, defined as aGFR < 30 mL/min/1.73 m2.
- Acute kidney injury, irrespective of eGFR levels.
- Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia.
- History of severe allergies, including 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.
9 secondary outcomes
To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.
Time frame: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.
Time frame: Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.
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.
Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
Diagnostic confidence of MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
Technical adequacy of MRI images of HRS-9231 and 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
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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?
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 Central Nervous System (CNS) Lesions, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 2 sites in China.
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?
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.