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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorE-Scopics

About this trial

The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 exam shall be performed (abdominal right upper quadrant)

Patient with a history of decompensated cirrhosis,

Trial design

Design model

Single group

Treatments tested in this trial

  • Liver ultrasound

    Device

    Hepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Main cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Correlation with MRI PDFF

Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC and SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017.

Time frame
At a maximum of 6 months from enrollment

Secondary outcomes

1

Comparison with Fibroscan CAP

Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05.

Time frame
At a maximum of 6 months from enrollment

Other outcomes

Sponsors and contacts

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