The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and… (NCT04682600) | Clinical Trial Compass
CompletedNot Applicable
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
United States164 participantsStarted 2020-10-21
Plain-language summary
The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults, 19-75 years old
* Healthy volunteers or Patients with evidence of NAFLD such as one of the following:
Previous liver biopsy consistent with NAFLD OR
Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria:
* Abdominal ultrasound within 12 months
* MRI-PDFF (greater than 12%) within 12 month
* FibroScan CAP score \> 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (\>8kPa) within 12 months
* Able to understand the informed consent form, study procedures and willing to participate in study
* If female and of child bearing potential, must agree to practice a highly effective contraception method.
Exclusion Criteria:
* Active viral hepatitis
a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible
* Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding)
* ALT or AST \> 5 x ULN on historical blood work within the past 3 months
* BMI greater than 40 kg/m2 (or using cutoff based on MRI)
* Other known causes of chronic liver disease
* Individuals with history of persistent ethanol abuse (alcohol consumption \> 20g etoh/day for women, \> 40 g etoh/day for men)
* Individuals with surgically removed gallbladder
* Pregnant or planning to become pregnant while enrolled in this study
* Othe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Elasticity measurements comparison between Liver Incytes MR Elastography
Timeframe: 12 months
2
Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging