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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascelia Pharma AB
• Treatments: Manganese

Criteria

Inclusion Criteria:

• Male and female participants 18 years and older.

• Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.

• Severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2) based on medical history and previous laboratory examinations within the last 3 months prior to the Baseline Visit, or participants with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days prior to the Baseline Visit.

Exclusion Criteria:

• Participants with simple liver cysts only.

• Any investigational drug or device within 6 weeks prior to the Baseline Visit.

• Any magnetic resonance imaging (MRI) contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.

• Participants with moderate or severe hepatic impairment (according to Child-Pugh score B or C).

• Participants currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis participants included in the pharmacokinetic (PK) subgroup.

• Participants scheduled for surgery before last study visit.

• Participants with encephalopathy / neurodegenerative or acute neurological disorders.

• Participants with hemochromatosis.