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

NCT06176079 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-12-19

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Hyperpolarized (HP) 13C

A dosage of 0.43 mL/kg body weight at the maximum dosage will be injected intravenously at a rate of 5 mL/second.

DRUG

Hyperpolarized 13C-Urea

Given intravenously (IV)

PROCEDURE

Magnetic Resonance Imaging

Imaging procedure

PROCEDURE

Saline Flush

A 20 milliliter (mL) saline flush at 5 mL/second will be given after each dose of HP 13C

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Michael Ohliger, MD PhD

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176079 on ClinicalTrials.gov