CompletedNot Applicable

Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis

France72 participantsStarted 2013-04

Plain-language summary

Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition. This proof of concept validation is made up of two steps: * Step 1: feasibility study of the method on 10 healthy volunteers * Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in: * Fibroscan measure, preceded by tracking ultrasonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions

Who can participate

Age range

18 Years – 65 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: * Healthy subjects - Steps 1 and 2 * Age between 18 and 65 years old (2 age groups for step 2 : 18-30 et 40-65 years-old) * Written inform consent form signed * Affiliated to medical insurance * Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men * Patients with liver steatosis - Step 2 * More than 18 years -old * Written inform consent form signed * Affiliated to medical insurance * Patients with clean steatosis confirmed by histological results of a liver biopsy done the previous month * Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men Exclusion Criteria: * Healthy subjects - Step 1 * Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks * Pregnant women, lactating women, and women in age for procreation and without reliable contraception * Presence of ascites * Person under guardianship * Healthy subjects - Step 2 * Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks * Pregnant women, lactating women, and women in age for procreation and without reliable contraception * Contraindication to MRI * Presence of ascites * Person under guardianship * Healthy subjects - Steps 1 and 2 * Presence of liver tumor or ascites (diagnosed with MRI or ultrasonography) * Abnormal liver function tests (increase of transaminases, gammaGT) * Patients with liver steatosis - Step 2 * Exposure to chemical poisons (solvents, paints, drugs) in the …

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

Viscosity in Pa.s

Timeframe: One day

Elasticity in kPa

Timeframe: One day

Trial details

NCT IDNCT02575625

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Liver Steatosis trials