A Study of Study of Free-Breathing Magnetic Resonance Elastography (MRE) of the Liver in Healthy Volunteers and Its Longitudinal Application in Patients with Chronic Liver Diseases

Overview

About this study

 The purpose of this study is to implement a free-breathing hepatic MRE technique capable of being performed in as little as 0.8 seconds per slice which could significantly reduce the breath-hold requirements for typical MRE exams, establish a rapid imaging protocol, and improve clinical patient throughput.

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:

  • Age ≥ 18 years.
  • Verbal and written fluency of the English language.
  • Able to consent.
  • Recruitment of 60 subjects who have clinically diagnosed chronic liver diseases that will have clinically indicated liver biopsy within one year of study enrollment and 10 subjects who have no known liver diseases.
  • Review Prepatory to Research #6485-18 and 6486-18 are on file to review EHRs of those referred to the study and those identified by liver biopsy procedure listings.
  • Consent taken by clinicians (study coordinators, GI physicians).
  • Participant fasting four hours before MRI scanning time.
  • Enrolled subjects will have hepatic MRI exam at study visits 1 and 2.Second visit to be completed within 30 days of visit one.
  • Hepatogram with free-breathing MRE performed at study visits 1 and 2.Second visit to be completed within 30 days of visit one.
  • Analysis of each hepatogram by radiology investigators (Sudhakar/Meng/Jiahui)- who are blinded.
  • Preliminary analysis of 10 subjects.
  • Continued recruitment.
  • Completion of 60 target subjects.

Exclusion Criteria:

  • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, deep brain stimulator, or severe claustrophobia.
  • History of decompensated cirrhosis complicated by one or more of the following: esophageal variceal hemorrhage, ascites, hepatic encephalopathy, or spontaneous bacterial peritonitis.
  • Women who are pregnant or breastfeeding.
  • History of liver transplantation or hepatic resection.
  • History of primary or secondary hepatic malignancy.
  • Current or previous excessive alcohol consumption within 6 months of study enrollment defined as > 30 grams/day for men and > 20 grams/day for women.
  • Current or prior history of therapy for underlying liver disease including interferon-based medications, other antiviral agents, immunomodulatory therapy, biologic response modifier therapy, and complementary/alternative medications including (but not encompassing) milk thistle.
  • Any severe medical condition that, in the opinion of the Principal Investigator, would serve as an exclusion criterion for study enrollment.
  • Body weight over 300 pounds (or 136 kilograms), chest/waist/hip circumference over 130 cm, and body mass index (BMI) over 40 kg/m2 due to MRI system limit (60-cm bore, <350lbs).

Patients who were previously consented under IRB 15-003148: adult subjects evaluated at Mayo Clinic with a diagnosis of NAFLD who are at risk to have NASH will be recruited from our outpatient Liver Disease Clinic.  Metabolic syndrome is a strong predictor of NASH and will be used to best identify subjects with a clinical indication for liver biopsy according to AASLD guidelines.  The inclusion and exclusion criteria are listed in the Table.

  • Inclusion Criteria:
    • Evidence of hepatic steatosis by imaging.
    • Metabolic risk factors (diabetes mellitus/impaired fasting glucose, dyslipidemia, hypertension, obesity).
    • Willing to participate and able to consent.
  • Exclusion Criteria:

    • Causes of secondary hepatic fat accumulation, such as excessive alcohol use (> 21 units/week in men, >14 units/week in women) or steatogenic medications (e.g. amiodarone, methotrexate, corticosteroids).
    • Other known chronic liver diseases.
    • Contraindications to MR imaging (e.g. claustrophobia, metallic aneurysmal clips, spinal stimulators etc.).
    • Contraindications to percutaneous liver biopsy (ascites, coagulopathy, mechanical biliary obstruction).

 

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

Meng Yin, Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Suzanne Greiner

(507)293-0913

Greiner.Suzanne2@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-20419680

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