Hepatic SteatosisSTEA-MRINCT03142698
Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
A study testing Quantification of hepatic steatosis in people with Hepatic Steatosis and MRI, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatic Steatosis, MRI, Liver Biopsy
- What is being tested?
- Quantification of hepatic steatosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2017to Sep 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
- signature of written consent
Who cannot join
- Contra-indications to MRI
- Refusal of protocol
- underage patients and protected adults
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Louis BOYER
About this study
Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis
Read the detailed description
Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).
The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.
Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.
At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.
Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.
- Measurement and influence of hepatic fibrosis
- Measurement and influence of intrahepatic iron
- Influence of intercurrent liver disease
- Comparison of the fat measurement of the different hepatic segments
- Reproducibility by measurement of inter-observer concordance
- Conditions
- Hepatic Steatosis, MRI, Liver Biopsy, Quantification
- Being tested
- Quantification of hepatic steatosis
- Keywords
- hepatic steatosis, MRImaging
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantification of hepatic steatosisProcedure or surgery
Quantification of hepatic steatosis (histology, and in MRI)
| Study group | Role | What they receive |
|---|---|---|
| Hepatic steatosis | Experimental | Evaluation of different techniques in quantification of hepatic steatosis by MRImaging (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the histological method (reference) Receives: Procedure: Quantification of hepatic steatosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Measured: at day 1
Secondary outcomes (4)
Measurement of intrahepatic iron
Measured: at day 1
Measurement of intrahepatic fibrosis
Measured: at day 1
Measurement of fat in different hepatic segments
(MRI )
Measured: at day 1
Concordance between observers
(for MRI measurements)
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startMay 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis BOYER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142698
- Sponsor's protocol ID
- CHU-317
- Other IDs
- 2016-A02065-46
- Acronym
- STEA-MRI
- Status last verified
- May 2017
- First submitted
- 13 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT03142698
- Acronym / sponsor ID
- STEA-MRI / CHU-317
- Conditions
- Hepatic Steatosis, MRI, Liver Biopsy, Quantification
- Keywords
- hepatic steatosis, MRImaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 5 May 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.
Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis
Detailed description
Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).
The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.
Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.
At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.
Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.
- Measurement and influence of hepatic fibrosis
- Measurement and influence of intrahepatic iron
- Influence of intercurrent liver disease
- Comparison of the fat measurement of the different hepatic segments
- Reproducibility by measurement of inter-observer concordance
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic steatosis | Experimental | Procedure: Quantification of hepatic steatosisEvaluation of different techniques in quantification of hepatic steatosis by MRImaging (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the histological method (reference) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
- signature of written consent
Key exclusion criteria (3 listed)
- Contra-indications to MRI
- Refusal of protocol
- underage patients and protected adults
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 |
|---|---|---|
| Quantification of hepatic steatosisQuantification of hepatic steatosis (histology, and in MRI) | Procedure or surgery | Hepatic steatosis |
Primary outcome
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Time frame: at day 1
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
4 secondary outcomes
Measurement of intrahepatic iron
Time frame: at day 1
Measurement of intrahepatic fibrosis
Time frame: at day 1
Measurement of fat in different hepatic segments
Time frame: at day 1
Concordance between observers
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Related trials for Hepatic Steatosis
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Not yet recruitingPhase 2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Type2diabetes
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
RecruitingPhase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
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.
Louis BOYER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantification of hepatic steatosis in people with Hepatic Steatosis and MRI, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrnd.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis. (time frame: at day 1). 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 5 May 2017.