NCT06176079

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Michael Ohliger, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: 1. Optimize scan parameters in order to maximize the signal-to-noise ratio of the HP 13C-pyruvate magnetic resonance imaging (MRI) in the liver. 2. Determine whether the level of lactate production (as measured by the lactate/pyruvate ratio) in NASH participants, participants with simple NAFL, and healthy volunteers. SECONDARY OBJECTIVES: 1. Develop data analysis methods to quantify HP C-13 pyruvate MRI data. 2. Further characterize the safety profile of HP C-13 pyruvate injections. EXPLORATORY OBJECTIVES: 1. Examine the impact of the dual liver blood supply on the vascular kinetics of observed hyperpolarized 13C metabolism. 2. Improve methods of quantification and motion correction for hyperpolarized 13C acquisition, incorporating perfusion information derived from 13C Urea OUTLINE: Part 1: (Imaging Optimization, N=50): Participants enrolled in Part 1 will predominantly be healthy volunteers. As the protocol optimization is completed, there is a possibility that testing in using data from participants with fatty liver disease may be performed. Participants in this part will be divided into two cohorts: * Cohort A: Participants will undergo MRI but no injection of hyperpolarized 13C. * Cohort B: Participants will receive one HP 13C injection. Participants in this cohort will have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP 13C-pyruvate+HP 13C-urea "copol", for up to a total of two injections per imaging visit. Part 2: (Pilot Study, N=30): Participants enrolled in Part 2 will receive the HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" protocol that was optimized in Part 1 as well as standard liver MRI pulse sequences. Participants will be stratified into the following groups based on diagnosis: * Group 1 (n=10): Participants with a diagnosis of non-alcoholic fatty liver without steatohepatitis (NAFL) * Group 2 (n=10): Participants with a diagnosis of non-alcoholic steatohepatitis (NASH) * Group 3 (n=10): Participants with no known liver disease (healthy volunteers) Participants will be followed for 2-4 days following imaging procedure.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-22
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-12-19
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study