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New contrast dye aims to sharpen MRI images of body lesions

NCT ID NCT07275723

Diagnosis Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests a new contrast agent called HRS-9231 for MRI scans of body parts (excluding the brain and spine). The goal is to see if it makes abnormal blood vessels or lesions show up as clearly as a standard contrast agent. About 309 adults who already need a contrast MRI are participating. Each person gets both the new and standard agent at different times to compare image quality and safety.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

309 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

vascular malformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

For contrast-enhanced magnetic resonance imaging (MRI) of abnormal vascular lesions in body regions excluding the central nervous system (CNS)

Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China