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

Phase 1

• Conditions: MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment; MedDRA version: 22.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-001599-12-SE
• Lead Sponsor: Ascelia Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-30
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

Male and female patients 18 years and older

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

Severe renal impairment such as:
a. Chronic kidney disease [CKD] (estimated glomerular filtrationrate [eGFR] < 30 mL/min/1.73 m2) based on medical history and previous laboratory examinations at least once within the last 3 months prior to the Baseline Visit , OR
b. Acute kidney injury (AKI) with an increase in serum creatinine = 0.3 mg/dL within 48 hours or = 50% within 7 days prior to the Baseline Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Patients with simple liver cysts only
Any investigational drug or device within 6 weeks prior to the Baseline Visit.
Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
Patients severe hepatic impairment (according to Child-Pugh score C).
Patients scheduled for surgery before last study visit.
Patients with encephalopathy / neurodegenerative or acute neurological disorders.
Patients with hemochromatosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified