PET Imaging for Fatty Liver Disease

Overseen By Dana Little, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Must not be taking: Anticoagulants

Disqualifiers: Alcohol abuse, Hepatitis B/C, Neurodegenerative disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the link between liver inflammation and brain inflammation, as well as memory problems, in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Researchers will employ PET imaging, a specialized scanning technique, to simultaneously examine the liver and brain. They will use 18F-DPA-714 and 18F-FDG, radiotracers in PET scans, to visualize inflammation. The goal is to discover new ways to understand and potentially treat conditions like Alzheimer's Disease and other dementias. Individuals who have had or plan to have a liver biopsy for MASLD may be suitable candidates for this study. As an Early Phase 1 trial, the study focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy, you cannot participate in the trial.

What prior data suggests that this PET imaging method is safe?

A previous study found that 18F-DPA-714 remains stable in humans, with minimal breakdown in the blood shortly after injection, indicating it is generally well-tolerated. Research has shown that 18F-FDG is commonly used in PET scans and is safe for assessing inflammation in the liver and brain.

As this is an early-phase trial, the researchers are still testing the treatment for safety. However, the use of these tracers in other studies suggests they are generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to diagnose and understand fatty liver disease using PET imaging. Unlike current methods, which often rely on invasive liver biopsies or indirect blood tests, this trial uses two different tracers, 18F-DPA-714 and 18F-FDG, to provide detailed images of the liver. These tracers help visualize inflammation and metabolic activity in the liver, offering a more precise and less invasive way to assess the condition. This could lead to earlier detection and better monitoring of fatty liver disease, ultimately improving patient outcomes.

What evidence suggests that this PET imaging method is effective for assessing liver and brain inflammation in MASLD-related ADRD?

Initial findings suggest that two imaging techniques, 18F-DPA-714 and 18F-FDG, help view inflammation in the liver and brain. In this trial, participants will undergo positron emission tomography scans using both 18F-DPA-714 and 18F-FDG. Research has shown that 18F-DPA-714 effectively tracks brain swelling caused by nerve cell damage. Another study found that 18F-FDG, which traces glucose, can image liver inflammation related to fatty liver disease. This is important because liver inflammation might link to brain inflammation and memory problems like Alzheimer's. These imaging methods could enhance understanding of the connection between liver and brain health, offering new insights into diseases like Alzheimer's. ^{1 2 4 6 7}

Who Is on the Research Team?

Guobao Wang, PhD

Principal Investigator

UC Davis Health Department of Radiology

Are You a Good Fit for This Trial?

This trial is for adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) who may also be experiencing cognitive decline. The study aims to explore the connection between liver inflammation and brain health using advanced PET imaging techniques.

Inclusion Criteria

Ability to provide informed consent

I have had, or will have, a liver biopsy for fatty liver disease within the last 6 months.

Exclusion Criteria

I am not pregnant or breastfeeding.

My body weight is under 225 kg.

I have a history of liver issues, but not due to non-alcoholic fatty liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants will undergo positron emission tomography scans with 18F-FDG and 18F-DPA-714 to assess neuroinflammation and liver-brain inflammation crosstalk

3 months

Multiple visits for imaging sessions

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DPA-714
• 18F-FDG

Trial Overview The trial is testing a new PET imaging method using two tracers, 18F-FDG and 18F-DPA-714, to assess inflammation in both the liver and brain of patients with MASLD-related cognitive issues. This could help understand how liver disease might affect Alzheimer's Disease.

How Is the Trial Designed?

Group I: Imaging Experimental Treatment 2 Interventions

Participants will undergo positron emission tomography scans. One scan will be performed after administration of 18F-FDG while the other will be perfomred after administration of 18F-DPA-714.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

The study successfully simplified the synthesis of the PET radiopharmaceutical [(18)F]FEDAC, achieving high-quality clinical-grade batches with a decay-corrected radiochemical yield of up to 52%.

Acute toxicity tests in rats showed no harmful effects from a single dose of [(18)F]FEDAC over 14 days, indicating its safety for potential use in first-in-human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient radiosynthesis and non-clinical safety tests of the TSPO radioprobe [(18)F]FEDAC: Prerequisites for clinical application. Kawamura, K., Kumata, K., Takei, M., et al.[2018]

Citations

1. withpower.com withpower.com/trial/early-phase-1-liver-diseases-6-2024-996db

PET Imaging for Fatty Liver Disease The drug 18F-DPA-714, 18F-FDG is unique for treating fatty liver disease because it uses PET imaging to detect inflammation and mitochondrial dysfunction in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10577118/

The effect of hepatic steatosis on 18F-FDG uptake in PET ... Hepatic steatosis causes a statistically significant increase in liver metabolic activity as measured by SUV mean and SUVmax values in fatty ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4893647/

18F-DPA-714 PET Imaging for Detecting Neuroinflammation ... F-DPA-714 PET can effectively quantify and monitor the treatment response to neuroinflammation in chronic liver failure and hyperammonemia rats- ...

4. ejrnm.springeropen.com ejrnm.springeropen.com/articles/10.1186/s43055-025-01456-7

Assessment of the effect of hepatic steatosis on 18F-FDG ... Unenhanced CT scans are effective in detecting steatosis when fatty infiltration exceeds 30%, as confirmed by liver biopsy. The sensitivity and ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.678144/full

Frontiers | [18F]PBR146 and [18F]DPA-714 in vivo Imaging ... Both [18F]PBR146 and [18F]DPA-714 had the similar imaging effects in hepatic encephalopathy models could quantitatively evaluate neuroinflammation load and ...

6. thno.org thno.org/v06p1220.htm

18 F-DPA-714 PET Imaging for Detecting ... F-DPA-714 PET can effectively quantify and monitor the treatment response to neuroinflammation in chronic liver failure and hyperammonemia rats [18-20]. Thus, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22172392/

Initial evaluation in healthy humans of [18F]DPA-714, a ... Modeling of regional brain and plasma data showed good in vivo stability of [(18)F]DPA-714 in humans, with only 20% of blood metabolites 20 min postinjection ( ...