Noninvasive evaluation of metabolic dysfunction-associated fatty liver disease with deep-learning models based on quantitative ultrasound :a multicenter study

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300075888

Enrollment

Unknown

Registered

2023-09-19

Start date

2023-09-20

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic dysfunction-associated fatty liver disease

Interventions

Gold Standard:Liver biopsy or magnetic resonance imaging of liver proton density fat fraction (MRI-PDFF)/magnetic resonance spectroscopy(MRS)

Index test:Tissue Attenuation Imaging

Tissue Scatter Distribution Imaging

Automatic Liver-kidney ratio measurement

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: MAFLD patients and normal controls scheduled for liver biopsy or magnetic resonance imaging proton density fat fraction (MRI-PDFF) or magnetic resonance spectroscopy (MRS) examination at our hospital. 1) Patients with MAFLD: ? Chinese citizens aged =18 years and =85 years; ? Meet the diagnostic criteria for metabolic-related fatty liver disease: the presence of hepatic steatosis on imaging or blood biomarkers/scores or liver histology, and one of the following three criteria, i.e., overweight/obesity (BMI =23 kg/m2 ), type 2 diabetes mellitus (T2DM), or metabolic dysregulation. Metabolic disorders were defined as at least two of the following abnormalities: (1) Waist circumference =90/80 cm (male/female); 2) Blood pressure = 130/85 mmHg or medication; 3) Plasma triglycerides =150 mg/dl (=1.70 mmol/L) or special drug therapy; 4) Plasma HDL cholesterol: 2 mg/L. (2) Normal control patients (1) Chinese citizens aged =18 years and =85 years; ? Chinese citizens aged =18 years and =85 years old. ? Normal range of BMI (18.5-23.9 kg/m2 ), normal liver as indicated by imaging or blood biomarkers/scoring or liver histology; ? Exclude metabolic related fatty liver disease, hyperlipidemia, diabetes and other related metabolic diseases; (iv) Exclude acute and chronic liver diseases such as hepatitis B and alcoholic liver disease;

Exclusion criteria

Exclusion criteria: 1 age 85 years old; 2 pregnant; 3 patients who have received or are undergoing systemic chemotherapy, or patients who have undergone TACE, and patients who have tumor in the detection site of the liver. 4 Other types of hepatitis, alcohol-related fatty liver disease (alcohol consumption in the past 12 months, equivalent to =30 g per day in men and =20 g per day in women), drug-induced liver disease or autoimmune hepatitis; 5 those who refuse to sign the informed consent; 6 significant risk of bleeding (platelet < 50x109/l, prothrombin activity < 50%).

Design outcomes

Primary

Measure	Time frame
Tissue Attenuation Imaging;Tissue Scatter Distribution Imaging;Automatic Liver-kidney ratio measurement;Shear wave elastography;Serum cholesterol;receiver operating characteristic curve,ROC;Sensitivity;specificity;Positive predictive value;Negative predictive value;	—

Secondary

Measure	Time frame
Spleen size;Aspartate transaminase;Alanine transaminase;Serum triglyceride;	—

Countries

China

Contacts

Public ContactXu Huixiong

Zhongshan Hospital, Fudan University

xu.huixiong@zs-hospital.sh.cn+86 189 1768 3519

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026