Liver SteatosisTRANSTEATOSENCT02575625
Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
A study testing Fibroscan, Blood test for biological assessment of liver function and MRI in people with Liver Steatosis, run by University Hospital, Tours at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Steatosis
- What is being tested?
- Fibroscan, Blood test for biological assessment of liver function and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 previous 4 weeks
- Pregnant women, lactating women, and women in age for procreation and without reliable contraception
- Contraindication to MRI
- Presence of ascites
- liver tumor
- Serology anti VHC+ or Ag HBs+
- Infection by HIV
- Auto-immun hepatitis
- Genetic hemochromatosis, Wilson disease, lake of alpha-1-antitrypsin
- Fibrosis or liver cirrhosis at biopsy
- Person under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
Read the detailed description
Diagnosis of liver lipid overload (named liver steatosis), unrelated to alcohol consumption, still mainly based on histological exam of the liver. An histological continuity exists going from clean liver steatosis (Non Alcoholic Fatty Liver Disease, NAFLD) to steatohepatitis with signs of inflammation and tissue fibrosis (Non Alcoholic Steato-Hepatitis, NASH). It's now well-known that disease can evolve to cirrhosis and its complications.
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).
Measures on healthy volunteers enable to do an intra-operator reproductibility analysis, a study of an age effect and a search of potential mechanic aging of the liver.
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
The final aim of this study is to propose a device enable medical community to do in vivo hepatic rheology observation, highly correlated to liver lipid overload. After industrialization of this innovation, this diffusion could making easier patients follow-up.
- Conditions
- Liver Steatosis
- Being tested
- Fibroscan, Blood test for biological assessment of liver function, MRI
- Keywords
- Liver steatosis, Steatohepatitis, Fibroscan
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.
Blood test for biological assessment of liver functionBiological
Blood test for biological assessment of liver function
MRIDevice
Liver MRI
| Study group | Role | What they receive |
|---|---|---|
| Fibroscan exam | Experimental | 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 hepatic biopsy et whom the histological answer is clean steatosis (NAFLD).
Experimental procedures consist in:
* Fibroscan measure, preceded by tracking sonography.
* liver MRI (for substudy about MRI comparison, in step 2)
* a blood test for biological assessment of liver functions Receives: Device: Fibroscan; Biological: Blood test for biological assessment of liver function; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viscosity in Pa.s
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
Measured: One day
Elasticity in kPa
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
Measured: One day
Secondary outcomes (3)
Reproductibility quantification in arbitrary unit
The 5 estimated parameters (which describe visco-elasticity) will be used to quantify the medical device reproductibility
Measured: through study completion, an average of 2 years
Age in years
The 5 estimated parameters (which describe visco-elasticity) and the age oh the healthy volunteers wil be used to study an age effect
Measured: through study completion, an average of 2 years
Liver signal intensity changes in decibel
Adiposis charge will be assessed by measure of liver signal intensity decrease on T1 sequence in phase opposition compared to in phase signal, after correction by iron quantity
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SteatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Echosens, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Frederic PATAT, MD, PhD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575625
- Sponsor's protocol ID
- PHAO2011-FP/TRANSTEATOSE
- Acronym
- TRANSTEATOSE
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
- ClinicalTrials.gov ID
- NCT02575625
- Acronym / sponsor ID
- TRANSTEATOSE / PHAO2011-FP/TRANSTEATOSE
- Conditions
- Liver Steatosis
- Keywords
- Liver steatosis, Steatohepatitis, Fibroscan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Echosens, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Diagnosis of liver lipid overload (named liver steatosis), unrelated to alcohol consumption, still mainly based on histological exam of the liver. An histological continuity exists going from clean liver steatosis (Non Alcoholic Fatty Liver Disease, NAFLD) to steatohepatitis with signs of inflammation and tissue fibrosis (Non Alcoholic Steato-Hepatitis, NASH). It's now well-known that disease can evolve to cirrhosis and its complications.
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).
Measures on healthy volunteers enable to do an intra-operator reproductibility analysis, a study of an age effect and a search of potential mechanic aging of the liver.
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
The final aim of this study is to propose a device enable medical community to do in vivo hepatic rheology observation, highly correlated to liver lipid overload. After industrialization of this innovation, this diffusion could making easier patients follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroscan exam | Experimental | Device: Fibroscan, Biological: Blood test for biological assessment of liver function, Device: MRIStep 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 hepatic biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in: * Fibroscan measure, preceded by tracking sonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subjects - Steps 1 and 2
- Patients with liver steatosis - Step 2
Key exclusion criteria (26 listed)
- Healthy subjects - Step 1
- Healthy subjects - Step 2
- Healthy subjects - Steps 1 and 2
- Patients with liver steatosis - Step 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanThree series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography. | Device | Fibroscan exam |
| Blood test for biological assessment of liver functionBlood test for biological assessment of liver function | Biological | Fibroscan exam |
| MRILiver MRI | Device | Fibroscan exam |
Primary outcome
Viscosity in Pa.s
Time frame: One day
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
Elasticity in kPa
Time frame: One day
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
3 secondary outcomes
Reproductibility quantification in arbitrary unit
Time frame: through study completion, an average of 2 years
Age in years
Time frame: through study completion, an average of 2 years
Liver signal intensity changes in decibel
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Clinical Investigation Center - Technological InnovationsLink provided by the sponsor.
- University Hospital of ToursLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic PATAT, MD, PhD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan, Blood test for biological assessment of liver function and MRI in people with Liver Steatosis, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viscosity in Pa.s (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.