For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) LesionsPhase 2NCT06731829
A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
A Phase 2 study testing HRS-9231 and Gadobutrol in people with For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 explore the effective dose of HRS-9231 for CNS MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects 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 and Gadobutrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Apr 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, no gender restrictions
- Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
- Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans
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
- Moderate to severe renal dysfunction, defined as aGFR < 60 mL/min
- Contraindications to MRI, such as metallic implants or claustrophobia
- History of severe allergies, including drugs, contrast agents, or other allergens
- Severe liver disease or cardiovascular disease, or related abnormal test results
- Central nervous system inflammation or recent history of stroke
Show all 11Show fewer
- Active infectious diseases, such as HIV, hepatitis B, or syphilis
- Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability
- Pregnancy, breastfeeding, or plans for conception, without effective contraception measures
- Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents
- Other conditions deemed unsuitable by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
People's Hospital, Peking University
Beijing, Beijing Municipality, 100000
Nan Hong
About this study
Official title: A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II 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 explore the effective dose of HRS-9231 for CNS MRI; 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, Gadobutrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9231Drug
HRS-9231
GadobutrolDrug
Gadobutrol
| Study group | Role | What they receive |
|---|---|---|
| HRS-9231 dose 1 | Experimental | Not described Receives: Drug: HRS-9231 |
| HRS-9231 dose 2 | Experimental | Not described Receives: Drug: HRS-9231 |
| HRS-9231 dose 3 | Experimental | Not described Receives: Drug: HRS-9231 |
| Gadobutrol | Active comparator | Not described Receives: Drug: Gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)
Measured: 1 day procedure
Secondary outcomes (4)
Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).
Measured: 1 day procedure
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.
Measured: 1 day procedure
Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.
Measured: 1 day procedure
HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).
Measured: 1 day procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
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.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731829
- Sponsor's protocol ID
- HRS-9231-201
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT06731829
- Acronym / sponsor ID
- HRS-9231-201
- Conditions
- For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Dec 2024 (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 explore the effective dose of HRS-9231 for CNS MRI; 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
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRS-9231 dose 1 | Experimental | Drug: HRS-9231 |
| HRS-9231 dose 2 | Experimental | Drug: HRS-9231 |
| HRS-9231 dose 3 | Experimental | Drug: HRS-9231 |
| Gadobutrol | Active comparator | Drug: Gadobutrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements
- Age ≥18 years, no gender restrictions
- Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
- Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans
Key exclusion criteria (11 listed)
- Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters
- Moderate to severe renal dysfunction, defined as aGFR < 60 mL/min
- Contraindications to MRI, such as metallic implants or claustrophobia
- History of severe allergies, including drugs, contrast agents, or other allergens
- Severe liver disease or cardiovascular disease, or related abnormal test results
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-9231HRS-9231 | Drug | HRS-9231 dose 1, HRS-9231 dose 2, HRS-9231 dose 3 |
| GadobutrolGadobutrol | Drug | Gadobutrol |
Primary outcome
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)
Time frame: 1 day procedure
4 secondary outcomes
Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).
Time frame: 1 day procedure
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.
Time frame: 1 day procedure
Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.
Time frame: 1 day procedure
HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).
Time frame: 1 day procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
RecruitingPhase 2/3
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
Known or Highly Suspected Central Nervous System (CNS) Lesion, Known or Highly Suspected Body (Excluding CNS) Lesion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9231 and Gadobutrol in people with For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junpeng Zhuang (+0518-82342973, junpeng.zhuang.jz5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol) (time frame: 1 day procedure). 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 12 Dec 2024.