NeuroFLiPP: Parametric PET of Neuroinflammation in Fatty Liver Disease

Phase 1

Not yet recruiting

• Conditions: Positron Emission Tomography

• Registration Number: NCT06453915
• Lead Sponsor: University of California, Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants >=18 years age<br><br> - Participants who have or have planned a liver biopsy as:<br><br> - standard of care for fatty liver disease with risk factors for metabolic<br> dysfunction-associated steatohepatitis (MASH), or<br><br> - as part of another Clinical Trials study for MASH, or<br><br> - standard of care prior to undergoing bariatric surgery<br><br> - Liver biopsy needs to be within 6 months of planned study-related imaging<br><br> - Ability to provide informed consent.<br><br>Exclusion Criteria:<br><br> - History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease<br> other than non-alcoholic fatty liver disease.<br><br> - Uncontrolled claustrophobia<br><br> - Body weight >225 kg due to limitations of the scanner bed<br><br> - Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test<br> will be administered prior to start of each PET/CT session for all participants<br> between 18 to 60 years old who are able to get pregnant, unless documented<br> hysterectomy is available)<br><br> - Concurrent or prior enrollment in a separate research study involving a PET scan<br> performed within the last 12 months for research purposes only.<br><br> - Prisoners<br><br> - Any comorbidity that, in the opinion of the investigator, could compromise protocol<br> objectives.<br><br> - Pre-existing neurodegenerative disorders and dementia<br><br> - Significant history of major skull concussion or repetitive head trauma<br><br> - Currently on anticoagulant therapy<br><br> - Metal implants (e.g., pacemaker) or claustrophobia that would preclude MRI scans

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
results of 18F-FDG scans compared with results of DPA-714 scans

Secondary Outcome Measures

Name	Time	Method
Compare levels of neuroinflammation detected using FDG and DPA-714 scans to the levels of liver inflammation determined through biopsies