Non-alcoholic Fatty Liver Disease NAFLDIRM-NASHNCT06626074
Exploratory Study of MRI Biomarkers of NASH
A study testing Quantitative MRI sequences in people with Non-alcoholic Fatty Liver Disease NAFLD, run by University Hospital, Angers at 2 sites in France.
Trial summary
Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries. NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease NAFLD
- What is being tested?
- Quantitative MRI sequences
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Sep 2025to 6 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
- Adult patient
- Free, informed and express (oral) consent of the patient to participate in the study
Who cannot join
- Contraindication to MRI
- Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
- Pregnant, parturient and breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under compulsion to psychiatric care
- Person subject to a legal protection measure
- Person not affiliated or not covered by a social security scheme.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital, Angers
Angers, France, 49000
Anita PAISANT, 0241353637 ext. +33, anita.paisant@chu-angers.fr
Marie BOST, 0241353637 ext. +33, MaBost@chu-angers.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Vanessa BRUN, MD, 02 99 28 96 63 ext. +33, Vanessa.brun@chu-rennes.fr
About this study
Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.
NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.
Read more
Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.
Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.
There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Being tested
- Quantitative MRI sequences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative MRI sequencesDevice
additional sequences during MRI
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | Not described Receives: Device: Quantitative MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
NASH is defined by histological criteria
Measured: the outcome measurment is performed once during MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start5 Sep 2025
- Primary completion5 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease NAFLDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Angers University
- Responsible party
- Sponsor
- Investigators
- Anita PAISANT, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626074
- Sponsor's protocol ID
- 49RC23_0262
- Other IDs
- 2024-A02056-41
- Acronym
- IRM-NASH
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of MRI Biomarkers of NASH
- ClinicalTrials.gov ID
- NCT06626074
- Acronym / sponsor ID
- IRM-NASH / 49RC23_0262
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Angers University
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 3 Oct 2024 (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.
Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.
NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.
Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.
Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.
There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Device: Quantitative MRI sequences |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
- Adult patient
- Free, informed and express (oral) consent of the patient to participate in the study
Key exclusion criteria (7 listed)
- Contraindication to MRI
- Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
- Pregnant, parturient and breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under compulsion to psychiatric care
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 |
|---|---|---|
| Quantitative MRI sequencesadditional sequences during MRI | Device | Open label |
Primary outcome
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
Time frame: the outcome measurment is performed once during MRI
NASH is defined by histological criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
Anita PAISANT, MD principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative MRI sequences in people with Non-alcoholic Fatty Liver Disease NAFLD, run by University Hospital, Angers at 2 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 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 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita PAISANT, MD (0241353637 ext. +33, anita.paisant@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis (time frame: the outcome measurment is performed once during MRI). 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 16 Jun 2026.