Phase 3
N=87
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Known or Suspected Focal Liver Lesions · Severe Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04119843 ↗Enrolled (actual)
87
Serious AEs
2.3%
Results posted
Feb 2025
Primary outcome: Primary: Co-primary Endpoint: Lesion Border Delineation in Combined MRI Compared to Unenhanced MRI — 2.51; 3.46; 3.00; 3.80 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mangoral (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascelia Pharma AB
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary Endpoint: Lesion Border Delineation in Combined MRI Compared to Unenhanced MRI |
2.51; 3.46; 3.00; 3.80; 2.31; 2.97 | <0.001 sig |
| PRIMARY Co-primary Endpoint: Lesion Contrast in Combined MRI Compared to Unenhanced MRI |
2.49; 3.47; 2.84; 3.86; 2.51; 3.33 | <0.001 sig |
| SECONDARY Number of Lesions Detected by Each MRI Method |
5.7; 6.2; 6.4; 3.5; 4.3; 4.2 | — |
| SECONDARY Lesion Border Delineation in Mangoral-enhanced MRI Compared to Unenhanced MRI |
2.57; 3.34; 2.95; 3.71; 2.27; 2.86 | <0.001 sig |
| SECONDARY Lesion Contrast in Mangoral-enhanced MRI Compared to Unenhanced MRI |
2.57; 3.52; 2.80; 3.53; 2.46; 3.18 | <0.001 sig |
| SECONDARY Confidence in Lesion Detection Score |
2.5; 2.8; 2.8; 2.8; 2.8; 2.8 | — |
| SECONDARY Confidence in Lesion Localization Score |
2.5; 2.9; 2.8; 2.7; 2.8; 2.8 | — |
| SECONDARY Longest Diameter of Largest and Smallest Lesion |
23.5; 21.4; 27.2; 25.3; 19.8; 17.0 | — |
| SECONDARY Percentage Liver Signal Intensity (SI) Enhancement in Mangoral-enhanced MRI Compared to Unenhanced MRI |
72.159; 59.633; 61.456 | — |
| SECONDARY Liver-to-lesion Contrast (LLC) in Mangoral-enhanced MRI Compared to Unenhanced MRI |
0.143; 0.306; 0.109; 0.291; 0.142; 0.331 | — |
| SECONDARY Signal-to-noise Ratio (SNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI |
286.428; 322.951; 226.367; 531.223; 248.653; 419.706 | — |
| SECONDARY Contrast-to-noise Ratio (CNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI |
56.564; 137.281; 33.506; 277.270; 91.019; 241.093 | — |
| SECONDARY Number of Participants With Change(s) in Recommended Management Based on Diagnostic Performance of Combined MRI or Mangoral-enhanced MRI Compared to Unenhanced MRI |
4; 4; 19; 21; 27; 29 | — |
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.
Eligibility 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, 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.
Data sourced from ClinicalTrials.gov (NCT04119843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.