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New treatment option for Non-Alcoholic Fatty Liver Disease
Official title Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients
ClinicalTrials.gov ID: NCT04785937
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- clinical indication to perform a liver biospy for NAFLD assessment based on all of the following:
- presence of liver steatosi at ultrasound
- at least one risk factor for NASH/fibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome)
- 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...
- consent to participate in the study
You likely can't join if
- 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...
- contraindications to perform liver biopsy (ascites, platelet count\ 1.5, PT\>50%, serum bilirubin \>3 mg/dL)
- contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)
The study team makes the final eligibility decision.
Where it's taking place
- Reggio Emilia, RE, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reggio Emilia, RE, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.