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Metabolic Dysfunction-Associated Liver DiseaseQAI_QSI_MRINCT07189650

Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density

An observational study of Metabolic Dysfunction-Associated Liver Disease, run by Esaote S.p.A..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this single-center, prospective, pilot study is to acquire data on liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease). Ultrasound attenuation (QAI) and scattering (QSI) imaging parameters will be acquired. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRI
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
30 Sep 2025to 30 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)

Who may be able to join

  • Previous diagnosis or suspected steatosic liver disease. The diagnosis may be suspected in the presence of concomitant conditions, such as (but not limited to) obesity, type 2 diabetes, pro-atherogenic dyslipidemia (hypertriglyceridemia, low HDL cholesterol), and metabolic syndrome;
  • Patients for whom an upper abdominal ultrasound is indicated as part of the clinical workup for the diagnosis and/or treatment of steatosic liver disease.

Who cannot join

  • Contraindications to MRI (patients with a pacemaker, metal implants, pregnant patients, claustrophobia, physical inability to perform the exam due to constitution);
  • Inappropriate alcohol consumption (>30 g/day for men and >20 g/day for women);
  • Viral liver disease (HBV, HCV, HIV);
  • Other forms of metabolic/autoimmune/cholestatic or storage liver disease e.g., primary biliary cholangitis, sclerosing cholangitis, hemochromatosis, Wilson's disease);
  • History of hepatocellular carcinoma or other forms of malignancy;
  • Refusal to participate in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Matteo Garcovich, MD, PhD contact

+39 0630156018

matteo.garcovich@policlinicogemelli.it

About this study

Official title: Collection of Quantitative Data on Liver Fat Content Obtained From Ultrasound Attenuation (QAI) and Scattering (QSI) Imaging and From Liver Fat Fraction Values Obtained by Magnetic Resonance Imaging With Proton Density Technique (MRI-PDFF)

The aim of this single-center, prospective, pilot study is to acquire data on liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease).

Ultrasound attenuation (QAI) and scattering (QSI) imaging parameters will be acquired.

Read more

Fat percentage parameters, obtained from magnetic resonance imaging with proton density technique (MRI-PDFF), will be acquired as well and they will be considered as reference method and gold standard.

The study is initiated for exploratory and research purposes. The study will enroll 30 consecutive, non-vulnerable adult participants who are scheduled to undergo upper abdominal ultrasound (Intervention A) as part of their standard clinical evaluation for the diagnosis and/or management of steatotic liver disease (SLD).

Eligible participants will be invited to provide informed consent to undergo an additional, non-invasive imaging procedure (Intervention B), consisting of magnetic resonance imaging with proton density fat fraction (MRI-PDFF) quantification

Read the detailed description

The primary endpoint of this exploratory study is to acquire data on liver adipose content in a population of adult patients affected by MASLD for comparing Ultrasound Imaging (QAI and QSI) and MRI (MRI-PDFF) methods

Being tested
MRI
Keywords
Metabolic Dysfunction-Associated Liver Disease,, MASLD, Ultrasound - Tissue attenuation Imaging, Ultrasound - Tissue scatter imaging, MRI - Proton Density Fat Fraction, QAI, QSI, MRI-PDFF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Proton Density Fat Fraction Magnetic Resonance Imaging (MRI-PDFF )

Study groups in NCT07189650
Study groupRoleWhat they receive
Single Cohortnot vulnerable, adult subjetcs affected by MASLD (Metabolic Dysfunction-Associated Liver Disease)
Receives: Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exploratory comparison of Ultrasound Imaging findings (Tissue Attenuation Imaging and Tissue Scatter Imaging) with MRI one (MRI-PDFF, considered as reference) in evaluating liver adipose content

    Exploratory and preliminary comparison of the findings obtained assessing liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease) utilizing Ultrasound Imaging (Tissue Attenuation Imaging and Tissue Scatter Imaging) technologies and MRI one (MRI-PDFF). The latter is considered as reference technology and gold standard

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start30 Sep 2025 (estimated)
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189650
Sponsor's protocol ID
CIP000004
Acronym
QAI_QSI_MRI
Status last verified
Sep 2025
First submitted
12 Sep 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers as this is a pilot-exploratory study that seek to generate hypotheses rather than a confirmatory study testing a specific, predetermined hypothesis with the goal of providing conclusive evidence in support of it.

Publications

  • Han A, Andre MP, Deiranieh L, Housman E, Erdman JW Jr, Loomba R, Sirlin CB, O'Brien WD Jr. Repeatability and Reproducibility of the Ultrasonic Attenuation Coefficient and Backscatter Coefficient Measured in the Right Lobe of the Liver in Adults With Known or Suspected Nonalcoholic Fatty Liver Disease. J Ultrasound Med. 2018 Aug;37(8):1913-1927. doi: 10.1002/jum.14537. Epub 2018 Jan 23.

    PubMed 29359454

  • Noureddin M, Lam J, Peterson MR, Middleton M, Hamilton G, Le TA, Bettencourt R, Changchien C, Brenner DA, Sirlin C, Loomba R. Utility of magnetic resonance imaging versus histology for quantifying changes in liver fat in nonalcoholic fatty liver disease trials. Hepatology. 2013 Dec;58(6):1930-40. doi: 10.1002/hep.26455. Epub 2013 Oct 17.

    PubMed 23696515

  • Ferraioli G, Berzigotti A, Barr RG, Choi BI, Cui XW, Dong Y, Gilja OH, Lee JY, Lee DH, Moriyasu F, Piscaglia F, Sugimoto K, Wong GL, Wong VW, Dietrich CF. Quantification of Liver Fat Content with Ultrasound: A WFUMB Position Paper. Ultrasound Med Biol. 2021 Oct;47(10):2803-2820. doi: 10.1016/j.ultrasmedbio.2021.06.002. Epub 2021 Jul 18.

    PubMed 34284932

  • Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.

    PubMed 19243014

  • Cholongitas E, Senzolo M, Standish R, Marelli L, Quaglia A, Patch D, Dhillon AP, Burroughs AK. A systematic review of the quality of liver biopsy specimens. Am J Clin Pathol. 2006 May;125(5):710-21. doi: 10.1309/W3XC-NT4H-KFBN-2G0B.

    PubMed 16707372

  • Dasarathy S, Dasarathy J, Khiyami A, Joseph R, Lopez R, McCullough AJ. Validity of real time ultrasound in the diagnosis of hepatic steatosis: a prospective study. J Hepatol. 2009 Dec;51(6):1061-7. doi: 10.1016/j.jhep.2009.09.001. Epub 2009 Sep 20.

    PubMed 19846234

  • Tamaki N, Ajmera V, Loomba R. Non-invasive methods for imaging hepatic steatosis and their clinical importance in NAFLD. Nat Rev Endocrinol. 2022 Jan;18(1):55-66. doi: 10.1038/s41574-021-00584-0. Epub 2021 Nov 23.

    PubMed 34815553

  • Eslam M, Sanyal AJ, George J. Toward More Accurate Nomenclature for Fatty Liver Diseases. Gastroenterology. 2019 Sep;157(3):590-593. doi: 10.1053/j.gastro.2019.05.064. Epub 2019 May 31. No abstract available.

    PubMed 31158374

  • Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.

    PubMed 24042449

  • European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.

    PubMed 27062661

  • Ress C, Kaser S. Mechanisms of intrahepatic triglyceride accumulation. World J Gastroenterol. 2016 Jan 28;22(4):1664-73. doi: 10.3748/wjg.v22.i4.1664.

    PubMed 26819531

  • Younossi ZM, Blissett D, Blissett R, Henry L, Stepanova M, Younossi Y, Racila A, Hunt S, Beckerman R. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016 Nov;64(5):1577-1586. doi: 10.1002/hep.28785. Epub 2016 Sep 26.

    PubMed 27543837

  • Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.

    PubMed 15565570

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Dysfunction-Associated Liver Disease, run by Esaote S.p.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matteo Garcovich, MD, PhD (+39 0630156018, matteo.garcovich@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exploratory comparison of Ultrasound Imaging findings (Tissue Attenuation Imaging and Tissue Scatter Imaging) with MRI one (MRI-PDFF, considered as reference) in evaluating liver adipose content (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07189650, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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