Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity (NCT01082419) | Clinical Trial Compass
CompletedNot Applicable
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity
France109 participantsStarted 2010-04
Plain-language summary
Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases. However, there is growing evidence that fibrosis is not the only determinant of liver stiffness. Indeed inflammation, cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.
Who can participate
Age range
18 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:
* Man or Woman
* Age\> 18 years old
* Able to understand the study and to give informed consent
* Informed consent signed by patient and investigator before any study required examination
* With a valid health insurance
* Groups specific inclusion criteria are:
* Group A : healthy volunteers without known liver disease
* Group B : voluntary patients without known liver disease
* Group C and D Patient with a diagnosed chronic liver disease
* Group E : patients with liver tumors (benign or malignant) with surgical indication
* Group F : patients with acute right heart insufficiency diagnosed by a cardiologist
* Group G :patients with biliary cholestasis and imaging evidence of biliary dilatation
Exclusion Criteria:
* Patient under 18 years old
* Not able to understand the study or to give their consent.
* Pregnant woman
* Severe respiratory insufficiency
* Unable to perform a "light" apnea .
* hemodynamic instability (cardiogenic shock, septic or anaphylactic) possibility of disruption of the elasticity and inability to carry patient.
* Chronic heart insufficiency.
* deprived of their liberty by court
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
The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
Timeframe: One or two 30 min visit according to the patient group