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Ultrasound Liver Fat Quantification (LFQ) – A Dual-center Study

Ultrasound Liver Fat Quantification (LFQ) – A Dual-center Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048806
Enrollment
Unknown
Registered
2021-07-16
Start date
2021-07-28
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatosis hepatitis (NASH)

Interventions

Gold Standard:MRI-PDFF uses the chemical shift-encoded (CSE) MRI methods that can quantify the relative amount of water and fat signal arising from tissue. CSE methods can accurately quantify the PDFF
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Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, able to provide written informed consent; 2. Eligible for standard abdominal ultrasound examination and standard non-enhanced MRI examination; 3. Attest to absent or minimal alcohol consumption (less than 30g of ethyl alcohol /day for men and less than 20g of ethyl alcohol /day for women); 4. At least meet one of the following criteria: (1) Overweight or obese (BMI >= 25); (2) Diagnosed with T2DM according to clinical guidelines; (3) Diagnosed with hypercholesterolemia according to clinical guidelines; (4) Diagnosed with or clinically suspected of NAFLD / NASH based on previous medical history, imaging examination, liver biopsy and/or other laboratory tests.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with evidence of hepatotoxicity; 3. Subjects with a history of chronic liver disease (e.g. viral hepatitis, cholestatic hepatitis, or autoimmune liver disease); 4. Subjects taking medication associated with liver steatosis, including amiodarone, methotrexate, nucleoside reverse transcriptase inhibitors (didanosine, deoxythymidine), valproate, dexamethasone, tamoxifen, adjuvant chemotherapy based on 5-fluorouracil, apolipoprotein B inhibitors; 5. During the enrollment period, subjects anticipated or planned diagnostic or therapeutic intervention and the Investigator believes this may affect the liver fat content (e.g., bariatric surgery, chemotherapy); 6. Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical 7. Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.

Design outcomes

Primary

MeasureTime frame
Hepato-renal index (HRI);Acoustic attenuation;Tissue stiffness;

Countries

China

Contacts

Public ContactLu Qiang

West China Hospital of Sichuan University

wsluqiang@126.com+86 18980606310

Outcome results

None listed

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