drugset / Trial / NCT04119843

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

NCT04119843

Phase 3 Completed 87 enrolled Ascelia Pharma AB
NaSingle-groupOpen-labelDiagnostic

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Manganese Chloride Other / unclassified Oral