Noninvasive measurement of liver fat and scarring with visual transient elastography
Official title: Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
Run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT07128108 · Data updated 2026-11-12
This study will test whether a noninvasive ultrasound method (ViTE with the Mindray Hepatus 9) can accurately measure liver fat and scarring in adults who recently had a liver biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 14, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07128108 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with documented liver injury who have had a liver biopsy within the past two weeks and who can consent to a ViTE exam using the Mindray Hepatus 9 are ideal candidates.
✕Probably not a fit
Patients with acute viral hepatitis, active right heart failure with very high transaminases or bilirubin, a history of hepatocellular carcinoma, pregnancy, implantable medical devices, or those outside the 18–65 age range are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multicenter study will use the Mindray Hepatus 9 system to perform Visual Transient Elastography (ViTE) and Liver Steatosis Analysis (LiSA) in adults with documented liver injury. Each ViTE/LiSA result will be compared to a contemporaneous liver biopsy, which is treated as the gold standard, to determine diagnostic accuracy for grading steatosis and fibrosis. The team will analyze results to establish diagnostic thresholds and performance metrics for both steatosis and fibrosis grading. Participants are adults aged 18–65 with a liver biopsy within the past two weeks and without acute viral hepatitis, pregnancy, implantable devices, or other key exclusions.
Why it matters
Potential benefit: If successful, this could provide a reliable noninvasive way to measure liver fat and scarring, reducing the need for repeat liver biopsies.
How similar studies have gone: Related elastography technologies (e.g., FibroScan, shear-wave methods) have shown good accuracy for fibrosis and steatosis, but ViTE/LiSA on the Mindray Hepatus 9 represents a newer implementation with more limited published validation to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be aged 18-65 years. * Documented liver injury of any etiology with a liver biopsy performed within the past 2 weeks. * Willing to undergo Visual Transient Elastography (ViTE) examination using Mindray Hepatus 9 Ultrasound System and capable of providing written informed consent. Exclusion Criteria: * Acute viral hepatitis. * Right heart failure with either:Serum transaminases \>5× upper limit of normal (ULN),Total bilirubin \>85.5 μmol/L. * History of hepatocellular carcinoma (HCC). * Pregnancy. * Patients with implantable medical devices.
Where it's running
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XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Chao Sun, PhD
- Email: csun7682@163.com
- Phone: 08613818676775
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.