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

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ClinicalTrials.gov Identifier: NCT04119843
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Ascelia Pharma AB

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Known or Suspected Focal Liver Lesions and Severe Renal Impairment Drug: Mangoral Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, open-label, pivotal phase III study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mangoral
All participants 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.) [ Time Frame: 1 year ]
    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

  2. Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI [ Time Frame: 1 year ]
    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

  3. Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI [ Time Frame: 1 year ]
    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

  4. Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI [ Time Frame: 1 year ]
    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

  5. Lesion dimensions: longest diameter of largest and smallest lesion [ Time Frame: 1 year ]
    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

  6. Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio) [ Time Frame: 1 year ]
    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

  7. Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  • 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 moderate or severe hepatic impairment (according to Child-Pugh score B or C).
  • Participants currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis participants included in the pharmacokinetic (PK) subgroup.
  • Participants scheduled for surgery before last study visit.
  • Participants with encephalopathy / neurodegenerative or acute neurological disorders.
  • Participants with hemochromatosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119843


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

Locations
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Sponsors and Collaborators
Ascelia Pharma AB
Investigators
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Principal Investigator: Bernd Hamm, MD Charite Berlin, Dept. of Radiology
More Information
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Responsible Party: Ascelia Pharma AB
ClinicalTrials.gov Identifier: NCT04119843    
Other Study ID Numbers: ASC-Man-P016
11-3429 ( Other Identifier: FDA Orphan Designation Request )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases