Purpose

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in patients 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) measured within the screening period, or patients with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days.

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 with moderate or severe hepatic impairment (according to Child-Pugh score B or C). - Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the pharmacokinetic (PK) subgroup. - Patients scheduled for surgery before last study visit. - Patients with encephalopathy / neurodegenerative or acute neurological disorders. - Patients with hemochromatosis.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Multicenter, open-label, pivotal phase III study
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mangoral
All patients will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).
  • Drug: Mangoral
    800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Recruiting Locations

Boston University Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Ascelia Pharma AB

Study Contact

Karin Liljeberg
+46 735 179 112
kl@ascelia.com

Detailed Description

The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in patients 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 patients 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.