RECRUITING

NeuroFLiPP: Parametric PET of Neuroinflammation in Fatty Liver Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Alzheimer's Disease and related dementias (ADRD) affect about 6 million people in the U.S. and are the fifth leading cause of death for adults over 65. Recent research is investigating how chronic liver diseases like Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which affects one-third of the U.S. population, might influence ADRD through the liver-brain axis. MASLD shares risk factors with Alzheimer's, such as diabetes and hypertension, and studies have linked MASLD to increased risks of cognitive decline and ADRD. Mouse-model studies suggest that chronic liver inflammation in MASLD can induce neuroinflammation and accelerate Alzheimer's pathology, highlighting the importance of studying the liver-brain connection to identify new therapeutic targets for ADRD. The goal of this research is to develop a practical PET imaging method using 18F-FDG to simultaneously assess liver and brain inflammation in patients with MASLD-related ADRD. This approach leverages dynamic FDG-PET scanning and advanced tracer kinetic modeling to quantify glucose transport, overcoming limitations of traditional imaging methods that cannot noninvasively assess chronic liver inflammation. The new method aims to enable comprehensive imaging of liver-brain inflammation crosstalk, validated against the 18F-DPA-714 radiotracer. Success in this project could provide a valuable imaging tool for linking liver inflammation with neuroinflammation and cognitive decline, advancing clinical research and potentially uncovering new pathways for ADRD treatment

Official Title

NeuroFLiPP - Parametric PET of Neuroinflammation in Fatty Liver Disease

Quick Facts

Study Start:2025-04-30
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06453915

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants \>=18 years age
  2. * Participants who have or have planned a liver biopsy as:
  3. * standard of care for fatty liver disease with risk factors for metabolic dysfunction-associated steatohepatitis (MASH), or
  4. * as part of another Clinical Trials study for MASH, or
  5. * standard of care prior to undergoing bariatric surgery
  6. * Liver biopsy needs to be within 6 months of planned study-related imaging
  7. * Ability to provide informed consent.
  1. * History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
  2. * Uncontrolled claustrophobia
  3. * Body weight \>225 kg due to limitations of the scanner bed
  4. * 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)
  5. * Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
  6. * Prisoners
  7. * Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.
  8. * Pre-existing neurodegenerative disorders and dementia
  9. * Significant history of major skull concussion or repetitive head trauma
  10. * Currently on anticoagulant therapy
  11. * Metal implants (e.g., pacemaker) or claustrophobia that would preclude MRI scans

Contacts and Locations

Study Contact

Dana Little, MS
CONTACT
916-734-7749
dalittle@ucdavis.edu

Principal Investigator

Guobao Wang, PhD
PRINCIPAL_INVESTIGATOR
UC Davis Health Department of Radiology

Study Locations (Sites)

UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Guobao Wang, PhD, PRINCIPAL_INVESTIGATOR, UC Davis Health Department of Radiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Positron Emission Tomography