Liver Fibrosis Due to NASHLFMRECTNCT06797596
Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
An observational study of Liver Fibrosis Due to NASH and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Fibronostics USA, Inc at 1 site in United States.
Trial summary
This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Alcohol Liver Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to 30 Aug 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: • The expected number of subjects is around N=100 adult patients with Steatotic Liver Disease (MASLD or MetALD) with either paired MRE historical report and LIVERFASt or MR and LIVERFASt.
Who may be able to join
- SLD with MASLD or MetALD Adult patients with:
- available historical report of MRE and LIVERFASt test
- at least fibrosis scoring available (steatosis and necro-inflammation imaging reports are requested equally when available).
- Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available
Who cannot join
- Participants identified as having risk factors for false positive/negative results for Liverfast (severe intravascular hemolysis-if condition is known-, acute hepatitis or severe cytolysis with ≥ 600 ALT values)
- Other comorbidities not compatible with the diagnosis of MASLD or MetALD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Advanced Gastroenterology & Surgery Associates
Lady Lake, Florida, 32159
About this study
Official title: Clinical Correlation Evaluation of the LIVERFAStTM Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against MR-based Liver Assessment, Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt performance for MR steatosis assessment in an United States adult miscellaneous population with available (historical) MR intracellular fat fraction assessment (ICFF) from a single tertiary US clinic.
Read the detailed description
- To assess the correlation and the strength of concordance of LIVERFASt for staging important liver lesions of fibrosis and steatosis against MR liver assessment of clinically significant (≥F2 stage), advanced fibrosis (≥F3 stage) and cirrhosis (F4 stage) (MRE, ct1) and steatosis (MR) in a SLD (MASLD, MetALD) adult US population.
- To assess the diagnostic performance [AUROC (95%CI)] of LIVERFASt for diagnosing important liver lesions of fibrosis, steatosis taking MR-based methods as surrogate gold-standard (MRE for fibrosis assessment and MR for steatosis quantification).
- Conditions
- Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Alcohol Liver Disease
- Keywords
- LIVERFASt, LIVERFASt Test, Noninvasive Test for the Liver, LIVERFASt for MASLD, LIVERFASt for MASH, Fibronostics, Liverfast fibrosis test, Liverfast steatosis test, Liverfast for MASLD and MASH, Liverfast for liver fibrosis, Liverfast plus MRE, Liverfast and MRE, Liverfast and other imaging tools
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
1/ Two-class concordance rate (kappa, p value) between MRE and LIVERFASt fibrosis test for each of the fibrosis endpoints (≥F2, ≥F3, F4)
Measured: 6 months
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
2/ AUROCs (95%CI) for fibrosis endpoints (≥F2, ≥F3, F4) and steatosis endpoints (≥S1, ≥S2 and S3) against surrogate gold-standard, MRE and MR-PDFF, respectively
Measured: 6 months
Secondary outcomes (1)
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
3/ Discordance analysis using independent clinical criteria (e.g. biopsy, other circulating or imaging NITs,)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startMay 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Fibrosis Due to NASHStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Fibronostics USA, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797596
- Sponsor's protocol ID
- FIBRO-LFASt-MRE-009-2024
- Acronym
- LFMRECT
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlation Evaluation of the LIVERFAStTM Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against MR-based Liver Assessment, Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
- ClinicalTrials.gov ID
- NCT06797596
- Acronym / sponsor ID
- LFMRECT / FIBRO-LFASt-MRE-009-2024
- Conditions
- Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Alcohol Liver Disease
- Keywords
- LIVERFASt, LIVERFASt Test, Noninvasive Test for the Liver, LIVERFASt for MASLD, LIVERFASt for MASH, Fibronostics, Liverfast fibrosis test, Liverfast steatosis test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fibronostics USA, IncUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt performance for MR steatosis assessment in an United States adult miscellaneous population with available (historical) MR intracellular fat fraction assessment (ICFF) from a single tertiary US clinic.
Detailed description
- To assess the correlation and the strength of concordance of LIVERFASt for staging important liver lesions of fibrosis and steatosis against MR liver assessment of clinically significant (≥F2 stage), advanced fibrosis (≥F3 stage) and cirrhosis (F4 stage) (MRE, ct1) and steatosis (MR) in a SLD (MASLD, MetALD) adult US population.
- To assess the diagnostic performance [AUROC (95%CI)] of LIVERFASt for diagnosing important liver lesions of fibrosis, steatosis taking MR-based methods as surrogate gold-standard (MRE for fibrosis assessment and MR for steatosis quantification).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • The expected number of subjects is around N=100 adult patients with Steatotic Liver Disease (MASLD or MetALD) with either paired MRE historical report and LIVERFASt or MR and LIVERFASt.
Key inclusion criteria (4 listed)
- SLD with MASLD or MetALD Adult patients with:
- Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available
Key exclusion criteria (2 listed)
- Participants identified as having risk factors for false positive/negative results for Liverfast (severe intravascular hemolysis-if condition is known-, acute hepatitis or severe cytolysis with ≥ 600 ALT values)
- Other comorbidities not compatible with the diagnosis of MASLD or MetALD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
Time frame: 6 months
1/ Two-class concordance rate (kappa, p value) between MRE and LIVERFASt fibrosis test for each of the fibrosis endpoints (≥F2, ≥F3, F4)
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
Time frame: 6 months
2/ AUROCs (95%CI) for fibrosis endpoints (≥F2, ≥F3, F4) and steatosis endpoints (≥S1, ≥S2 and S3) against surrogate gold-standard, MRE and MR-PDFF, respectively
1 secondary outcome
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population.
Time frame: 6 months
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 13 Mar 2025.
- Related InfoLink 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.
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 Liver Fibrosis Due to NASH and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Fibronostics USA, Inc at 1 site in United States.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Mar 2025. 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 United States. 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 Garth George, MD (352-638-3982, spicedoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population. (time frame: 6 months). 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 13 Mar 2025.