NCT04785937 Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients
| NCT ID | NCT04785937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2022-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2019-01-01 with a primary completion date of 2022-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks. Several drugs for NASH are now in phase 2-3 trials, and if medical treatments become available, non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed. Some imaging methods have shown promising potential in fibrosis and NASH diagnosis. This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods, including ultrasound (US) and Magnetic Resonance (MR) techniques, in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the reference standard. Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study. They undergo both a liver US and a multiparametric unenhanced liver MR examination. As reference standard, histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression (FLIP) algorithm is used. Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90% sensitivity/specificity compared to liver biopsy.
Eligibility 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)
Contact & Investigator
Pierpaolo Pattacini, MD
STUDY DIRECTOR
Azienda USL - IRCCS di Reggio Emilia
Frequently Asked Questions
Who can join the NCT04785937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04785937 currently recruiting?
Yes, NCT04785937 is actively recruiting participants. Contact the research team at giulia.besutti@ausl.re.it for enrollment information.
Where is the NCT04785937 trial being conducted?
This trial is being conducted at Reggio Emilia, Italy.
Who is sponsoring the NCT04785937 clinical trial?
NCT04785937 is sponsored by Azienda USL Reggio Emilia - IRCCS. The principal investigator is Pierpaolo Pattacini, MD at Azienda USL - IRCCS di Reggio Emilia. The trial plans to enroll 50 participants.