Non-Alcoholic Fatty Liver DiseaseFibroMRNCT03245606
Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by Rennes University Hospital at 9 sites in France.
Trial summary
The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Liver biopsy, Abdominal MRI and Transient elastography
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 270 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Dec 2017to 7 Jul 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NAFLD
Who may be able to join
- Patients older than 18 years old
- For which a liver biopsy is indicated for NAFLD according to current guidelines
- Presenting with at least one of the metabolic syndrome criteria:
- BMI > 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women
- Fasting glucose > or = to 5,6 mmol/L or diabetes / or lowering glucose treatment
- Blood pressure ≥ 130/85 mmHg / or treatment
Show all 10Show fewer
- Triglycerides ≥ than 1,7 mmol/L
- HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment
- Affiliated to medical care insurance
- Having signed informed consent for participating in the study
Who cannot join
- Associated other chronic liver disease : infectious, auto immune, genetic
- Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
- Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
- History of bariatric surgery
- Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Angers
Angers, 49933
CHU de Bordeaux
Bordeaux, 33604
CHD Vendée
La Roche-sur-Yon, 85925
Groupe Hospitalier Bretagne Sud
Lorient, 56100
CHU de Nantes
Nantes, 44035
CHU de Rennes
Rennes, 35033
CH de Saint Brieuc
Saint-Brieuc, 22027
CHU de Toulouse
Toulouse, 31059
Centre Hospitalier Bretagne Atlantique
Vannes, 56000
About this study
Official title: Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)
The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.
Read the detailed description
No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.
Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.
To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :
- Magnetic Resonance Imaging can quantify liver steatosis accurately.
- Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.
- Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.
The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Liver biopsy, Abdominal MRI, Transient elastography
- Keywords
- NAFLD, steatosis, fibrosis, transient elastography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyProcedure or surgery
Measurement of liver fibrosis
Abdominal MRIDevice
Measurement of liver fibrosis
Transient elastographyDevice
Measurement of liver fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Patients with Non Alcoholic Fatty Liver Disease | Patients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions.
Then will be performed:
* a liver biopsy
* an abdominal MRI
* a transient elastography Receives: Procedure: Liver biopsy; Device: Abdominal MRI; Device: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD
Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist
Measured: Day 1
Secondary outcomes (4)
Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
Measured: Day 1
Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
Measured: Day 1
Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
Measured: Day 1
Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start7 Dec 2017
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245606
- Sponsor's protocol ID
- 35RC16_9794_FibroMR
- Acronym
- FibroMR
- Status last verified
- Jul 2020
- First submitted
- 7 Aug 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masrour O, Ehrhard F, Guillaume M, Boursier J, Gournay J, Aziz K, Schnee M, Garlantezec R, de Ledinghen V, Morcet J, Laine F, Allaume P, Turlin B, Gandon Y, Bardou-Jacquet E. Diagnostic accuracy of transient elastography in MASLD is independent of MRI-PDFF steatosis in a multicenter study. JHEP Rep. 2025 Sep 11;7(12):101589. doi: 10.1016/j.jhepr.2025.101589. eCollection 2025 Dec.
PubMed 41334457
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT03245606
- Acronym / sponsor ID
- FibroMR / 35RC16_9794_FibroMR
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, steatosis, fibrosis, transient elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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.
The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.
Detailed description
No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.
Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.
To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :
- Magnetic Resonance Imaging can quantify liver steatosis accurately.
- Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.
- Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.
The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Non Alcoholic Fatty Liver Disease | – | Procedure: Liver biopsy, Device: Abdominal MRI, Device: Transient elastographyPatients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions. Then will be performed: * a liver biopsy * an abdominal MRI * a transient elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NAFLD
Key inclusion criteria (10 listed)
- Patients older than 18 years old
- For which a liver biopsy is indicated for NAFLD according to current guidelines
- Presenting with at least one of the metabolic syndrome criteria:
- Affiliated to medical care insurance
- Having signed informed consent for participating in the study
Key exclusion criteria (6 listed)
- Associated other chronic liver disease : infectious, auto immune, genetic
- Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
- Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
- History of bariatric surgery
- Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
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 |
|---|---|---|
| Liver biopsyMeasurement of liver fibrosis | Procedure or surgery | Patients with Non Alcoholic Fatty Liver Disease |
| Abdominal MRIMeasurement of liver fibrosis | Device | Patients with Non Alcoholic Fatty Liver Disease |
| Transient elastographyMeasurement of liver fibrosis | Device | Patients with Non Alcoholic Fatty Liver Disease |
Primary outcome
Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD
Time frame: Day 1
Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist
4 secondary outcomes
Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
Time frame: Day 1
Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
Time frame: Day 1
Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
Time frame: Day 1
Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
Time frame: Day 1
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 14 Jul 2020.
- Derived from this study: PubMed 41334457Masrour O, Ehrhard F, Guillaume M, Boursier J, Gournay J, Aziz K, Schnee M, Garlantezec R, de Ledinghen V, Morcet J, Laine F, Allaume P, Turlin B, Gandon Y, Bardou-Jacquet E. Diagnostic accuracy of transient elastography in MASLD is independent of MRI-PDFF steatosis in a multicenter study. JHEP Rep. 2025 Sep 11;7(12):101589. doi: 10.1016/j.jhepr.2025.101589. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Rennes University Hospital at 9 sites 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 10 inclusion and 6 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245606, which also lists 1 linked publication.
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 14 Jul 2020.