A Study to Evaluate the Safety and Diagnostic Effectiveness of Mangoral in Patients With Focal Liver Lesions and Reduced Kidney Function

Overview

About this study

The overall purpose of this study is to evaluate the safety and diagnostic effectiveness of Mangoral in liver MRI in patients 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male and female patients 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) measured within the screening period, or patients with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days.

Exclusion Criteria:

  • Any investigational drug or device within 6 weeks prior to the Baseline Visit.
  • Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
  • Patients with moderate or severe hepatic impairment (according to Child-Pugh score B or C).
  • Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the pharmacokinetic (PK) subgroup.
  • Patients scheduled for surgery before last study visit.
  • Patients with encephalopathy / neurodegenerative or acute neurological disorders.
  • Patients with hemochromatosis, iron deficiency anemia, or are on iron therapy within 14 days prior to the Baseline Visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sudhakar Venkatesh, M.D.

Contact us for the latest status

Contact information:

Kathy Brown

(507) 538-1321

brown.kathy@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alvin Silva, M.D.

Open for enrollment

Contact information:

Saran Vaughn

(480) 342-6487

Vaughn.Saran@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Candice Bolan, M.D.

Open for enrollment

Contact information:

Kendra Brown M.P.H., CCRP

Brown.Kendra@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20505485

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