New MRI dye aims to sharpen brain scan images
NCT ID NCT07275814
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This phase 3 trial tests a new contrast agent called HRS-9231 for MRI scans of the brain and spine. The goal is to see if it works as well as the standard contrast agent (gadobutrol) at making lesions visible. About 250 adults with known or suspected brain or spine lesions will receive both agents in a crossover design, and their scans will be compared.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-9231 injection (a contrast agent for MRI)
- What this could lead to
- If successful, HRS-9231 could offer a new option for clearer brain and spine MRI scans, potentially improving diagnosis of lesions.
- What could go wrong
- This is a non-inferiority trial, so HRS-9231 may not be better than existing contrast agents. It is also still under investigation, so safety and effectiveness are not yet fully established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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250 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements. 2. Age ≥ 18 years, male or female. 3. 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. Exclusion Criteria: 1. Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters. 2. Severe renal impairment, defined as aGFR \< 30 mL/min/1.73 m2. 3. Acute kidney injury, irrespective of eGFR levels. 4. Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia. 5. History of severe allergies, including drugs, contrast agents, or other allergens. 6. Severe cardiovascular disease. 7. Female subjects who are pregnant or breastfeeding. 8. Other conditions deemed unsuitable by the investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China