Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults

NCT06373536 | Not Yet Recruiting

• 1 other identifier: LMU-RAD-01167
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\'s most common liver disease and affects around 33% of the adult population. Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH. In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide.

Conditions

Steatosis of Liver

Keywords

MRI-PDFF; Thermoacoustics

Outcome Measures

Primary Outcomes (2)

• Thermoacoustic Fat Measurements

  Perform thermoacoustic fat measurements for 80 participants, by one or more qualified operators, over the span of the study in order to determine the correlation of thermoacoustic derived fat fraction measures of steatotic liver disease to measurements obtained by MRI-PDFF.

  May 2024 to September 2025

• Estimate Accuracy of Thermoacoustic Fat Fraction

  Estimate the accuracy of thermoacoustic derived fat fraction measurements of steatotic liver disease by comparing to the established standard of MRI-PDFF measurements of liver fat fraction

  May 2024 to September 2025

Secondary Outcomes (2)

• Usability Metric

  May 2024 to January 2025

• Estimate Operator Variability

  May 2024 to January 2025

Interventions

Thermoacoustic imaging, MRI and Ultrasound imaging DIAGNOSTIC_TEST

This is a Thermoacoustic imaging exam that will last 10-15 minutes. Distinguishing; assessment of steatosis liver disease in obese and morbidly obese patients.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to radiology for abdominal imaging and suspected of having steatotic liver disease.

You may qualify if:

• Study participants are 18-70 years of age
• Existing MRI-PDFF not older than 6 weeks or routine MRI-PDFF in the following 6 weeks
• Be able to understand, read, and provide written informed consent in German
• Tolerant to ultrasound and MRI examinations
• Able to lay flat for 20 minutes

You may not qualify if:

• Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices.
• Known pregnancy the day of consent, or becoming pregnant during study participation
• Liver disease other than NAFLD/NASH including, but not limited to, hepatitis, cirrhosis, hepatocellular carcinoma.
• Patients with broken, or injured skin, in the right upper abdominal quadrant.
• BMI over 43 kg/m2

Sponsors & Collaborators

• Endra Lifesciences: lead

Study Sites (1)

Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie

München, 81377, Germany

Location

MeSH Terms

Conditions

Fatty Liver

Interventions

Magnetic Resonance Imaging; Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Dirk-Andre Clevert, Prof. Dr.

CONTACT

+49 89 44007 3635; Dirk.Clevert@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 18, 2024
• Study Start: June 21, 2024
• Primary Completion: June 21, 2025
• Study Completion: September 1, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-04

Locations

DE (1)