Resumen

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.

Descripción detallada

The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in participants with known or suspected focal liver lesions and severe renal impairment. Study treatment is a single oral dose of Mangoral (800 mg manganese chloride \[II\] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3). Adult male and female participants with severe renal impairment or acute kidney injury and who are being evaluated for known or suspected focal liver lesions will be included. Primary diagnostic efficacy in terms of visualization of detected lesions will be evaluated centrally by 3 independent readers. Study MRIs will also be evaluated by the on-site radiologists for the assessment of secondary objectives and for clinical purposes.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Mangoral

800 mg manganese chloride \[II\] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Ubicaciones

Fundación Intecnus

Bariloche, Río Negro Province, Argentina

Centro Rossi Body Imaging

Buenos Aires, Argentina

Sanatorio Allende Nueva Córdoba

Córdoba, Argentina

Patrocinadores

PrincipalAscelia Pharma AB

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment