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Could a quick liver scan replace needle biopsies for MASH in diabetics?

NCT ID NCT07632677

Diagnosis Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive liver scan called iLivTouch to see if it can accurately detect a serious liver condition called MASH in people who have both type 2 diabetes and fatty liver disease. The scan measures liver inflammation, fat, and stiffness without any needles. Researchers aim to enroll 10,000 adults in China to see if this tool can reliably diagnose MASH, potentially reducing the need for invasive liver biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iLivTouch (non-invasive liver scan)
What this could lead to
If successful, this could provide a simple, needle-free way to diagnose MASH in people with diabetes and fatty liver, replacing invasive biopsies.
What could go wrong
This is an observational study, not a treatment trial. The new index may not be accurate enough to replace biopsies, and results may not apply outside China.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult patients concurrently diagnosed with Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Participants will be continuously enrolled from both outpatient clinics and inpatient departments across 22 major research centers and tertiary hospitals located in various geographic regions of China. This cohort represents a real-world clinical population seeking routine medical care, health evaluations, or regular follow-ups for their metabolic and endocrine conditions. Data will be collected through both prospective clinical assessments and retrospective medical record reviews.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged ≥18 years, with no restrictions on sex; 2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition). Exclusion Criteria: 1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination; 2. Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases; 3. History of hepatic decompensation; 4. History of hepatectomy or liver transplantation; 5. History of other malignancies; 6. Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion; 7. History of transjugular intrahepatic portosystemic shunt (TIPS); 8. Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF); 9. Clinical or subclinical hypothyroidism or hyperthyroidism.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mash - metabolic dysfunction-associated steatohepatitis Metabolic dysfunction-associated fatty liver disease Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University

    RECRUITING

    Xi’an, Shanxi, 710032, China

  • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Department of Endocrinology, Hainan General Hospital

    RECRUITING

    Haikou, Hainan, 570311, China

  • Department of Endocrinology, Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310020, China

  • Department of Endocrinology, Xuzhou Central Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221009, China

  • Department of Endocrinology, ZhongShan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Department of Endocrinology, Zhujiang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510280, China

  • Department of Endocrinology, the Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, 563000, China

  • Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Shenzhen, Guangdong, 518033, China

  • Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, Anhui, 233004, China

  • Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Department of Endocrinology, the First Affiliated Hospital of Henan University of CM

    RECRUITING

    Zhengzhou, Hennan, 450099, China

  • Department of Endocrinology, the First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • Department of Endocrinology, the First Affiliated Hospital of University of South China

    RECRUITING

    Hengyang, Hunan, 421001, China

  • Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University

    RECRUITING

    Wuhu, Anhui, 241000, China

  • Department of Endocrinology, the Third People's Hospital of Yunnan Province

    RECRUITING

    Kunming, Yunnan, 650011, China

  • Department of Metabolic Diseases and Weight Management, Weifang People's Hospital

    RECRUITING

    Weifang, Shandong, 261000, China

  • Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, 511495, China

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