Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Summary
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
Timeline
- Start
- 2020-02-19
- Primary completion
- 2023-02-17
- Completion
- 2023-02-17
Outcome
Met primary endpoint
registry analysis (superiority test); Unenhanced MRI vs Combined MRI; p <0.001; Mean Difference (Final Values) 0.95 (95% CI 0.743 to 1.165); t-test, 1 sided NCT04119843 ↗
registry analysis (superiority test); Unenhanced MRI vs Combined MRI; p <0.001; Mean Difference (Final Values) 0.98 (95% CI 0.759 to 1.196); t-test, 1 sided NCT04119843 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Manganese Chloride | Other / unclassified | — | Oral |