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 : January 27, 2023
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Condition or disease | Intervention/treatment | Phase |
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Known or Suspected Focal Liver Lesions and Severe Renal Impairment | Drug: Mangoral | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 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 : | February 2023 |
Estimated Study Completion Date : | February 2023 |
Arm | Intervention/treatment |
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Experimental: Mangoral
All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).
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Drug: Mangoral
800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3 |
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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

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
Contact: Karin Liljeberg | +46 735 179 112 | sparkle@ascelia.com |

Principal Investigator: | Bernd Hamm, MD | Charite Berlin, Dept. of Radiology |
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: | January 27, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Renal Insufficiency Kidney Diseases Urologic Diseases |