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

Completed · Phase 3

Conditions studied: Known or Suspected Focal Liver Lesions, Severe Renal Impairment

In brief

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.

Key facts

Study ID

NCT04119843

Run by

Ascelia Pharma AB

People needed

87

Starts

2020-02-19

Expected to finish

2023-02-17

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, at least once, 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.

You may not qualify if…

• 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 severe hepatic impairment (according to Child-Pugh score C).
• Participants scheduled for surgery before last study visit.
• Participants with encephalopathy / neurodegenerative or acute neurological disorders.
• Participants with hemochromatosis.

Where it is running

• University of California at Los Angeles Ronald Reagan Medical Center — Los Angeles, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Schiff Center for Liver Diseases — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• PanAmerican Clinical Research LLC — Brownsville, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Fundación Intecnus — Bariloche, Río Negro Province, Argentina
• Centro Rossi Body Imaging — Buenos Aires, Argentina
• Sanatorio Allende Nueva Córdoba — Córdoba, Argentina
• Hospital Pablo Tobon Uribe — Medellín, Antioquia, Colombia
• Clínica Universitaria Colombia — Bogotá, Cundinamarca, Colombia
• Sociedad de Cirugía de Bogotá - Hospital de San José — Bogotá, Cundinamarca, Colombia
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie — Frankfurt, Germany
• Universitätsmedizin Göttingen — Göttingen, Germany
• Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie — Karlsruhe, Germany
• Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie — Kiel, Germany
• Mayo Clinic - Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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