NeuroFLiPP: Parametric PET of Neuroinflammation in Fatty Liver Disease

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jun 5, 2024

Keywords

ClinConnect Summary

The NeuroFLiPP trial is studying how inflammation in the liver may affect conditions like Alzheimer’s disease and related dementias. Researchers believe that chronic liver diseases, such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), might contribute to cognitive decline due to a connection between the liver and the brain. This study aims to develop a new type of imaging test called PET (Positron Emission Tomography) that can measure inflammation in both the liver and the brain at the same time, which could help in finding new treatments for Alzheimer’s.

To participate in this study, you must be at least 18 years old and have a planned liver biopsy for your fatty liver disease. This could be part of standard care or another clinical trial. However, some people may not be eligible, including those with certain liver diseases, a history of severe head trauma, or specific medical conditions that could interfere with the study. If you join, you'll undergo imaging tests that will help researchers learn more about the relationship between liver and brain inflammation. This could lead to important discoveries in treating Alzheimer’s and related conditions.

Gender

ALL

Eligibility 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