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Part 1 (Cohort A): No injection of hyperpolarized (HP) 13C for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Michael Ohliger, MD
Research Sponsored by Michael Ohliger, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean kPL(Part 2)
Mean lactate-to-pyruvate ratio (Part 2)
Mean lactate/pyruvate conversion rate (kPL) (Part 1, Cohort B)
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2 (Group 3): Healthy VolunteersExperimental Treatment4 Interventions
Healthy volunteers without known liver disease will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences.
Group II: Part 2 (Group 2): NASHExperimental Treatment4 Interventions
Participants with diagnosed NASH will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences.
Group III: Part 2 (Group 1): NAFLDExperimental Treatment4 Interventions
Participants with diagnosed NAFLD will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences.
Group IV: Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol"Experimental Treatment4 Interventions
Participants will receive HP 13C injection, and receive an MRI scan. Imaging results will be used to optimize the hyperpolarized 13C part of the imaging procedure. Participants will also have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol", (up to a total of two injections per imaging visit separated by 15-60 minutes). Participants may be asked to fast up to 6 hours prior to the scan and the initial HP 13C MRI scan may be taken while participants are in a fasted state. Participants who have fasted will be offered up to 20 ounces (oz) of an oral glucose, fructose, or other high calorie drink (i.e. Gatorade, Coca-Cola, Ensure, etc.) to increase blood glucose levels, and a second HP 13C MRI scan will be performed after caloric intake.
Group V: Part 1 (Cohort A): No injection of hyperpolarized (HP) 13CExperimental Treatment1 Intervention
Participants who are comprised of, primarily, healthy volunteers will undergo a standard MRI scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

Michael Ohliger, MD PhDLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,986 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,892 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Michael Ohliger, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want to get in the field of studies like my old friend once did.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease
Michael Ohliger, MD PhD 2020. "Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176079.
All > Sacramento
~15 spots leftby Feb 2025
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