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NCT04119843 Clinical Trial

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

Severe Renal Impairment Clinical Trial

— SPARKLE  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04119843
Other study ID # ASC-Man-P016
Secondary ID 11-3429
Status Completed
Phase Phase 3
First received
Last updated
Start date February 19, 2020
Est. completion date February 27, 2023

Study information
Verified date March 2024
Source Ascelia Pharma AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mangoral
800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3
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Sponsors (1)
Lead Sponsor Collaborator
Ascelia Pharma AB

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Germany,  Italy,  Mexico,  Poland,  Russian Federation,  Sweden,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI. Visualization will be measured by 2 co-primary variables: lesion border delineation and lesion contrast compared to liver background. Central reading sessions by 3 independent readers for all 3 parts (CMRI, Mangoral-enhanced MRI plus unenhanced MRI). There will be a 2-weeks gap between read parts to reduce recall bias. 1 year
Secondary Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.) Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Lesion dimensions: longest diameter of largest and smallest lesion Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio) Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
Secondary Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination 1 year
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