Non Alcoholic Fatty Liver DiseaseUDFFNCT06080386
UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
An observational study of Non Alcoholic Fatty Liver Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to assess UDFF performance (compared to MRI) 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?
- UDFF
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 15 Oct 2023
- 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 followed by the department of hepato gastroenterology of the CHU d'Angers for liver disease (NAFLD)
Who may be able to join
- All patients who had hepatic ultrasound with available UDFF measurements and hepatic MRI (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included.
Who cannot join
- chronic liver disease with a different etiology other than NAFL/NASH or mixed (hepatitis B or C, hemochromatosis, autoimmune hepatitis, Wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency),
- decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices),
- hepatocellular carcinoma.
- opposition to the use of its data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers university hospital
Angers, 49000
Marie Bost, +33 2 41 35 31 88, mabost@chu-angers.fr
Christophe Aubé
About this study
The purpose of this study is to assess UDFF performance (compared to MRI)
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- UDFF
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDFFDiagnostic test
quantification of liver fat: UDFF (lipid fraction derived from ultrasound) from one of the probes of an ultrasound system
| Study group | Role | What they receive |
|---|---|---|
| one group | Patients who had during their care UDFF ultrasound measurements and liver MRI over the study period may be included in this study Receives: Diagnostic Test: UDFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte.
Steatosis value measured by multiecho sequences in MR
Measured: 3 months maximum between the 2 measurements (UDFF and MRi)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Mar 2022
- Primary completion1 Sep 2023
- Study completion15 Oct 2023 (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 DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080386
- Sponsor's protocol ID
- 202300122
- Acronym
- UDFF
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
- ClinicalTrials.gov ID
- NCT06080386
- Acronym / sponsor ID
- UDFF / 202300122
- Conditions
- Non Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 12 Oct 2023 (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 purpose of this study is to assess UDFF performance (compared to MRI)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Diagnostic Test: UDFFPatients who had during their care UDFF ultrasound measurements and liver MRI over the study period may be included in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients followed by the department of hepato gastroenterology of the CHU d'Angers for liver disease (NAFLD)
Key inclusion criteria (1 listed)
- All patients who had hepatic ultrasound with available UDFF measurements and hepatic MRI (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included.
Key exclusion criteria (4 listed)
- chronic liver disease with a different etiology other than NAFL/NASH or mixed (hepatitis B or C, hemochromatosis, autoimmune hepatitis, Wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency),
- decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices),
- hepatocellular carcinoma.
- opposition to the use of its data
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 |
|---|---|---|
| UDFFquantification of liver fat: UDFF (lipid fraction derived from ultrasound) from one of the probes of an ultrasound system | Diagnostic test | one group |
Primary outcome
To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte.
Time frame: 3 months maximum between the 2 measurements (UDFF and MRi)
Steatosis value measured by multiecho sequences in MR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- 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.
1 site 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 University Hospital, Angers 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 1 inclusion and 4 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 12 Oct 2023. 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 Christophe Aubé (+33 2 41 35 42 81, chaube@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte. (time frame: 3 months maximum between the 2 measurements (UDFF and 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 12 Oct 2023.