Viewing Study NCT06176079



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Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06176079
Status: RECRUITING
Last Update Posted: 2023-12-19
First Post: 2023-12-10

Brief Title: Hyperpolarized Pyruvate 13C Magnetic Resonance Imaging In Patients With Fatty Liver Disease
Sponsor: Michael Ohliger MD PhD
Organization: University of California San Francisco

Study Overview

Official Title: Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate 13C In Patients With Fatty Liver Disease
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 lactatepyruvate 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 N50 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-pyruvateHP 13C-urea copol for up to a total of two injections per imaging visit

Part 2 Pilot Study N30 Participants enrolled in Part 2 will receive the HP 13C-pyruvate or HP13C-pyruvateHP13C-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 n10 Participants with a diagnosis of non-alcoholic fatty liver without steatohepatitis NAFL
Group 2 n10 Participants with a diagnosis of non-alcoholic steatohepatitis NASH
Group 3 n10 Participants with no known liver disease healthy volunteers

Participants will be followed for 2-4 days following imaging procedure

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01DK115987 NIH None httpsreporternihgovquickSearch5R01DK115987