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Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Not Recruiting
Trial ID: NCT04119843
Purpose
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.
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
Stanford Investigator(s)
Ryan Brunsing
Clinical Assistant Professor, Radiology
Eligibility
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.
Intervention(s):
drug: Mangoral
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brittney Williams
650-736-3688