RECRUITING

Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease

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Conditions

Non-Alcoholic Fatty Liver DiseaseNon Alcoholic Fatty LiverNon Alcoholic SteatohepatitisNAFLDNASH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The recent development of dissolution dynamic nuclear polarization (DNP) technology for hyperpolarized (HP) 13C imaging offers a promising new avenue for non-invasively accessing fundamental metabolic changes associated with the progression of fatty liver disease in vivo. The purpose of this pilot study is to optimize sequence parameters for hyperpolarized 13C acquisition in the human liver and determine which metabolic changes can be seen in humans with simple, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) when compared to healthy volunteers.

Official Title

Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease

Quick Facts

Study Start:2020-07-22
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06176079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able and willing to sign informed consent.
  2. 2. Age \>= 18 years old at the time of study entry.
  3. * Group 1 (Fatty Liver Patients without NASH):
  4. 1. NAFL as determined by either clinical suspicion of fatty liver disease based on:
  5. 1. steatosis by imaging or histology,
  6. 2. no significant alcohol consumption,
  7. 3. absence of coexisting liver disease OR NAFL determined by liver biopsy 3 months prior to the scan, with the presence of fat on histology but absent ballooning or fibrosis. (nonalcoholic steatohepatitis activity score (NAS) \<= 3).
  8. 2. Able and willing to sign informed consent.
  9. 3. Age ≥ 18 years old at the time of study entry.
  10. 4. Alcohol consumption \< 2 drinks/day for men and \<1 drink/day for women
  11. 5. Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody, human immunodeficiency virus (HIV) antibody negative.
  12. 6. Serum alanine aminotransferase (ALT) \< 400 microliter (uL)
  13. * Group 2 (NASH Patients):
  14. 1. NASH as determined by liver biopsy 3 months prior to the scan.
  15. 2. Able and willing to sign informed consent.
  16. 3. Age \>= 18 years old at the time of study entry.
  17. 4. Alcohol consumption \< 2 drinks/day for men and \<1 drink/day for women
  18. 5. HBsAg, HCV antibody, HIV antibody negative.
  19. * Group 3 (Healthy volunteer):
  20. 1. No known history of diabetes or liver disease.
  21. 2. Able and willing to sign informed consent.
  22. 3. Age \>= 18 years old at the time of study entry.
  23. 4. Body mass index \< 25.
  24. 5. Liver panel normal (aspartate aminotransferase (AST), ALT, alkaline phosphatase, bilirubin).
  25. 6. HBsAg, HCV antibody, HIV antibody negative.
  26. 7. Hemoglobin A1c \< 5.7%.
  27. 8. Estimated glomerular filtration rate (eGFR) \>= 60 mL/min/1.73m\^2
  1. 1. Poorly controlled hypertension, with blood pressure at study entry \> 160 mmHg systolic or \> 100 mmHg diastolic.
  2. 2. Congestive heart failure with New York Heart Association (NYHA) status ≥ 2.
  3. 3. Pregnant or nursing.
  4. 4. Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including participants with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
  5. 5. Participant size too large to fit in MR scanner.
  6. 1. Poorly controlled hypertension, with blood pressure at study entry \> 160 mmHg systolic or \> 100 mmHg diastolic.
  7. 2. Current treatment with oral medication for diabetes.
  8. 3. Pregnant or nursing.
  9. 4. Participants unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
  10. 5. Participant size too large to fit in MR scanner.
  11. 6. Congestive heart failure with New York Heart Association (NYHA) status \>= 2.

Contacts and Locations

Study Contact

Louise Magat
CONTACT
(415) 502-1822
Louise.Magat@ucsf.edu

Principal Investigator

Michael Ohliger, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Michael Ohliger, MD PhD

  • Michael Ohliger, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-22
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2020-07-22
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Alcoholic Fatty Liver Disease
  • Non Alcoholic Fatty Liver
  • Non Alcoholic Steatohepatitis
  • NAFLD
  • NASH