drugset / Trial / NCT07275723
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
RandomizedCrossoverTriple-blindDiagnostic
Summary
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.
Timeline
- Start
- 2025-11-14
- Primary completion
- 2026-04-18
- Completion
- 2026-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gadobutrol | Diagnostic / imaging agent | — | — |
| Subject | HRS-9231 | Diagnostic / imaging agent | — | — |
Indications
No indication recorded.