PET imaging of brain and liver inflammation in fatty liver disease
NeuroFLiPP - Parametric PET of Neuroinflammation in Fatty Liver Disease
This research will test whether PET scans using 18F-FDG and 18F-DPA-714 can see inflammation in both the liver and brain of adults with fatty liver disease who have recent or planned liver biopsies.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06453915 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional study develops a parametric PET protocol using 18F-FDG and 18F-DPA-714 to image liver and brain inflammation in people with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants must be adults with an existing or planned liver biopsy within six months and able to provide informed consent; key exclusions include other chronic liver disease, alcohol abuse, pregnancy, uncontrolled claustrophobia, and weight over 225 kg. Dynamic PET/CT scans will be acquired at the UC Davis EXPLORER Molecular Imaging Center to generate simultaneous liver and brain parametric images and correlate imaging signals with biopsy and clinical data. The overall aim is to create a practical, noninvasive imaging biomarker to study the liver–brain axis in ADRD and inform future therapeutic strategies.
Who should consider this trial
Good fit: Adults (≥18) with fatty liver disease who have or plan to have a liver biopsy within six months, can give informed consent, and meet safety criteria (no other chronic liver disease, no active alcohol abuse, not pregnant, and weight ≤225 kg) are ideal candidates.
Not a fit: People without fatty liver disease, with other chronic liver diseases or active alcohol abuse, pregnant or breastfeeding individuals, or those unable to undergo PET/CT (for example due to severe claustrophobia or weight over 225 kg) are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this imaging approach could provide a noninvasive way to detect and track liver-driven neuroinflammation and help identify patients who might benefit from targeted therapies.
How similar studies have performed: TSPO and FDG PET have been used separately to image neuroinflammation and metabolism and preclinical mouse studies support a liver–brain link, but simultaneous parametric PET of liver and brain inflammation in MASLD-related ADRD is a novel clinical approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants \>=18 years age * Participants who have or have planned a liver biopsy as: * standard of care for fatty liver disease with risk factors for metabolic dysfunction-associated steatohepatitis (MASH), or * as part of another Clinical Trials study for MASH, or * standard of care prior to undergoing bariatric surgery * Liver biopsy needs to be within 6 months of planned study-related imaging * Ability to provide informed consent. Exclusion Criteria: * History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease. * Uncontrolled claustrophobia * Body weight \>225 kg due to limitations of the scanner bed * Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy is available) * Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. * Prisoners * Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives. * Pre-existing neurodegenerative disorders and dementia * Significant history of major skull concussion or repetitive head trauma * Currently on anticoagulant therapy * Metal implants (e.g., pacemaker) or claustrophobia that would preclude MRI scans
Where this trial is running
Sacramento, California
- UC Davis EXPLORER Molecular Imaging Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Guobao Wang, PhD — UC Davis Health Department of Radiology
- Study coordinator: Dana Little, MS
- Email: dalittle@ucdavis.edu
- Phone: 916-734-7749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.