Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

Launched by E-SCOPICS · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new ultrasound device called the Hepatoscope, which is designed to check for fat in the liver without needing any invasive procedures. This trial is specifically looking at patients with conditions related to metabolic syndrome, such as metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatopathy (MASLD). Researchers want to see how well the Hepatoscope works compared to existing methods like MRI, which is a more traditional imaging technique used to assess liver fat.

To participate in this trial, you need to be an adult under 80 years old and have been diagnosed with MASLD or MASH. You should also be involved in other studies that require MRI assessments. If you join, the process will involve using the new ultrasound device to measure liver fat, and you'll help researchers understand how effective it is. It’s important to note that certain people, such as those with specific liver diseases or who are pregnant, cannot participate. The trial is not yet recruiting, but it aims to improve how we assess liver conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patient below 80 yo
• • Patients with MASLD/MASH recruited in interventional trials requiring MRI PDFF +/- MRE per interventional protocol, OR
• • Patients with MASLD/MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per interventional protocol, OR
• • Patients referred to MRI-PDFF or MRE.
• • Patients who consented in written to participate in the study
• • Patients with ongoing social security coverage
• Exclusion Criteria:
• • Patient in their minority (less than 18 yo) or older than 80 yo,
• • Patient with active implants,
• • Patient presenting with a wound where the Hepatoscope exman shall be performed (abdominal right upper quadrant)
• • Patient with a history of decompensated cirrhosis,
• • Patient with a history of hepatocellular carcinoma,
• • Adult patient under tutorship, or unable to express informed consent,
• • Pregnant or breast-feeding
• • Person deprived from their liberty
• • Patient hospitalized without providing consent or in case of an emergency
• • Patient presenting with another know liver disease