Imaging to diagnose steatohepatitis and liver fibrosis in people with fatty liver
Accuracy of Imaging Techniques Including Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Steatohepatitis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease: Comparison With the Histological Reference Standard
This study will test whether ultrasound and MRI scans can accurately detect steatohepatitis and liver fibrosis in adults with NAFLD who are scheduled for a liver biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 1 site (Reggio Emilia, RE) |
| Trial ID | NCT04785937 on ClinicalTrials.gov |
What this trial studies
The study enrolls consecutive adults referred for liver biopsy to evaluate suspected NAFLD and performs standardized ultrasound and magnetic resonance techniques, including MR spectroscopy and elastography, before biopsy. Imaging findings will be compared with histology from liver biopsy as the reference standard to measure diagnostic accuracy for NASH and fibrosis staging. The protocol is designed to determine whether non-invasive imaging can reliably identify patients who may need treatment and reduce reliance on biopsy. A non-inferiority framework will be used to compare imaging performance against the biopsy standard.
Who should consider this trial
Good fit: Adults with ultrasound-detected steatosis plus at least one risk factor (obesity, type 2 diabetes, or metabolic syndrome) and abnormal liver enzymes or elevated fibrosis scores who are scheduled for a diagnostic liver biopsy are ideal candidates.
Not a fit: People under 18, those with secondary causes of liver steatosis, known other diffuse liver diseases, or contraindications to biopsy or MRI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, validated imaging tests could reduce the need for invasive liver biopsies and help identify patients who would benefit from emerging therapies.
How similar studies have performed: Some MRI and ultrasound methods (for example MRE, MRI-PDFF, and transient elastography) have shown promising accuracy for fibrosis and fat quantification, but non-invasive diagnosis of NASH is still less well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical indication to perform a liver biospy for NAFLD assessment based on all of the following: 1. presence of liver steatosi at ultrasound 2. at least one risk factor for NASH/fibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome) 3. increased liver enzymes (at least one of: GOT\>40 U/l, GPT\>49 U/l, GGT\>75 U/l) or high NAFLD fibrosis score (\>0.675), or intermediate NAFLD fibrosis score (between -1.455 and 0.675) and increased liver stiffness at transient elastography (\>7 KPa). * consent to participate in the study Exclusion Criteria: * age \< 18 years * secondary causes of liver steatosis (moderate to severe alcohol consumption, steatogenic drugs) * known diffuse liver diseases other than NAFLD (cirrhosis, viral or autoimmune hepatitis, hemochromatosis, amiloidosis, other) or previous primary or secondary liver neoplasms * contraindications to perform liver biopsy (ascites, platelet count\<50.000/mmc, INR\>1.5, PT\>50%, serum bilirubin \>3 mg/dL) * contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)
Where this trial is running
Reggio Emilia, RE
- Azienda USL-IRCCS di Reggio Emilia — Reggio Emilia, Re, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Besutti, MD
- Email: giulia.besutti@ausl.re.it
- Phone: +390522296369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.