Metabolic Dysfunction-steatohepatitis (MASH)NCT07860814
Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy
An observational study of Metabolic Dysfunction-steatohepatitis (MASH), run by Radnet Management, Inc. at 3 sites in United States.
Trial summary
This is a prospective, non-interventional, observational study to evaluate the accuracy of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness: UDFF (ultrasound-derived fat fraction) and pSWE (point shear wave elastography) for determining MRI-defined eligibility for resmetirom (REZDIFFRA®)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-steatohepatitis (MASH)
- How many people
- 524 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2026to Oct 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants must be fully informed of the potential benefits of approved products and make an informed decision that they prefer to participate in a clinical study. Regulatory, ethical, and study oversight considerations are provided in the protocol. Participants will be recruited from clinical practices in the Houston, Texas area by hepatologists, gastroenterologists, and other referring clinicians. * Participants in the Pilot Study will be healthy adult males or females, age ≥18 years. * Participants in the Main Study will be adult males or females, age ≥18 years, suspected of MASH with moderate to advanced fibrosis consistent with F2-F3. Participants will be eligible if they meet ALL inclusion criteria and NONE of the exclusion criteria at Screening.
Who may be able to join
- Participants must meet the following criteria:
- Healthy adults (≥18 years) with no known liver diseases
- Participants must meet the following criteria:
- Adults (≥18 years) suspected of MASH with moderate to advanced fibrosis consistent with F2-F3 with no other known liver disease
Who cannot join
- Participants meeting ANY of the following criteria will be excluded:
- Use of steatogenic or hepatotoxic medications (eg, corticosteroids such as prednisone, amiodarone, methotrexate, tamoxifen)
- Contraindications to MRI
- Pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
HMI/Campbell
Houston, Texas, 77055
Senior Vice President of Research, +1 562-981-6101, Kristi.Maya@radnet.com
Clinical Research Regulatory Specialist, +1 562-206-7701, Jacqueline.Bral@radnet.com
HMI/Energy Corridor
Houston, Texas, 77079
Senior Vice President of Research, +1 562-981-6101, Kristi.Maya@radnet.com
Clinical Research Regulatory Specialist, +1 562-206-7701, Jacqueline.Bral@radnet.com
HMI/Pearland
Pearland, Texas, 77581
Senior Vice President of Research, +1 562-981-6101, Kristi.Maya@radnet.com
Clinical Research Regulatory Specialist, +1 562-206-7701, Jacqueline.Bral@radnet.com
About this study
Official title: Accuracy of Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy Using MRI as the Reference Standard
This is a prospective, non-interventional, observational study to evaluate the accuracy of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness: UDFF (ultrasound-derived fat fraction) and pSWE (point shear wave elastography) for determining MRI-defined eligibility for resmetirom (REZDIFFRA®) treatment and for monitoring treatment response using MRI-PDFF (proton density fat fraction) and MRE (magnetic resonance elastography) as reference standards.
Study Centers Planned:
Read more
3 clinical practice facilities in Houston TX .
Study Rationale:
MASLD (metabolic dysfunction-associated steatotic liver disease ) is a growing global epidemic and the most common liver disease worldwide. Approximately 25% of adults in the United States alone have hepatic steatosis in the absence of significant alcohol consumption and 1 in 4 of these adults are presumed to have MASH.
MASH has a higher likelihood of progression to irreversible liver damage including cirrhosis and hepatocellular carcinoma.
Despite advancements in the field, there is still a high unmet need for technologies to accurately and reliably grade liver steatosis and stage liver fibrosis for applications related to patient identification and monitoring response to therapeutic intervention.
The association between hepatic steatosis and fibrosis progression underscores the need to have accurate and reliable noninvasive tools to aid in the assessment and monitoring of both liver steatosis and fibrosis.
The combination of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness (UDFF and pSWE) may aid clinicians in streamlining patient care pathways and potentially avoid unwanted and invasive medical intervention.
Read the detailed description
This study will consist of 3 phases:
- Technologist Training: Pre-study training will be conducted for all US (ultrasound) and MRI technologists to ensure standardized image acquisition across study sites.
- A Pilot Study will be conducted in healthy adult participants to qualify imaging centers to participate in the Main Study.
- The Main Study will be conducted in adult participants suspected of MASH (metabolic dysfunction-steatohepatitis) (with moderate to advanced fibrosis consistent with F2-F3 to evaluate the diagnostic performance of the combination of 2 US (ultrasound) biomarkers (UDFF and pSWE) for determining MRI-defined eligibility for resmetirom treatment and for monitoring treatment response over time .
A Pilot Study will be conducted before the Main Study to verify image acquisition quality and data completeness, and to assess repeatability (US) and reproducibility (US and MRI). The Pilot Study will include 24 adult participants (n=8 participants/site across 3 imaging centers).
Each participant in the pilot study will undergo 4 US (ultrasound) scans (2 scans each by 2 Certified US Technologists).
All US scans will be performed on SIEMENS ACUSON Sequoia systems using the 5C1 transducer and the same software version throughout the study. Repeated US scans will be separated by ≥5 minutes, with participants repositioned between scans by the Certified US Technologists.
Each participant in the pilot study will also undergo 2 MRI scans (1 scan each by 2 Certified MRI Technologists):
MR scans will be performed using either the SIEMENS MAGNETOM Skyra 3T or GE SIGNA PIONEER 3T, depending on scheduling and site availability. The MR scanner will be running the same software version throughout the study.
Data from participants in the Pilot Study will not be included in the analysis of the Main Study.
Data Quality Verification :
All pilot data will be reviewed by Siemens to verify image acquisition quality, completeness, and adherence to the imaging protocol.
Repeatability and reproducibility will be evaluated in the Pilot Study.
Main Study
Participants will be recruited from clinical practices in the Houston, Texas area by hepatologists, gastroenterologists, and other referring clinicians. US (ultrasound) and MRI examinations will be performed across 3 Sponsor imaging centers in the Houston area. All participants will undergo Baseline US (ultrasound) biomarkers (UDFF, pSWE) and MRI biomarkers (MRI-PDFF, MRE) on the same day.
Blinding
- Referring physicians will be blinded to US (ultrasound) (UDFF and pSWE) results, and thus decisions to prescribe resmetirom will be made based solely on MRI biomarkers (ie, MRI-PDFF and MRE) and clinical assessment.
- US (ultrasound) operators will be blinded to results from MRI biomarkers (MRI-PDFF and MRE).
- MRI operators will be blinded to results from US (ultrasound) biomarkers (UDFF and pSWE).
Duration of Study Participation
- Pilot Study: 1 day, in addition to the Screening Visit
- Main Study :
- Participants NOT treated with resmetirom: Screening(consenting)and day 1 baseline MRI and US(2 visits total);
- Participants treated with resmetirom (prescribed by their referring physician based on Baseline MRI results and clinical assessment): Screening (consenting), day 1 baseline MRI and US then at months 6, 12 and 24 (5 visits total).
Study Assessments
- Record demographics
- Record medication history since last visit
- Record laboratory test results since last visit
- Perform US (ultrasound)
- Perform MRI
- Record/report SAEs
- Keywords
- MASH, MASLD, UDFF, pSWE, MRI-PDFF, MRE, Madrigal, Siemens, RadNet, Elastography, Resmetirom, Rezdiffra, MRI, ultrasound, biomarkers, fatty, liver, fibrosis, steatosis, stiffness
- Medical subject headings
- Fibrosis, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of UDFF (ultrasound-derived fat fraction)
Ultrasound criteria associated with elevated liver fat at baseline: UDFF ≥8%
Measured: Enrollment Day 1 Baseline
Diagnostic performance of Ultrasound pSWE (point shear wave elastography)
Ultrasound criteria consistent with MASH F2-F3 fibrosis at baseline: pSWE ≥7 and <17 kPa
Measured: Enrollment Day 1 Baseline
Secondary outcomes (5)
The accuracy of the Ultrasound biomarker pSWE (point shear wave elastography) for monitoring resmetirom treatment response over time.
Percent changes in Ultrasound pSWE from baseline to follow-up period are tested for statistical equivalence.
Measured: 6 months to 24 months of follow-up period
The accuracy of the Ultrasound biomarker UDFF (ultrasound-derived fat fraction) for monitoring resmetirom treatment response over time.
Percent changes in UDFF from baseline to follow-up period are tested for statistical equivalence
Measured: 6 months to 24 months of follow-up period
Corresponding percent changes in MRI-PDFF (proton density fat fraction) from baseline to follow- up period are tested for statistical equivalence
MR criteria associated with elevated liver fat at baseline: PDFF ≥8%
Measured: 6 months to 24 months follow-up period
Corresponding percent changes in MRE (magnetic resonance elastography) from baseline to followup period are tested for statistical equivalence
MR criteria consistent with MASH F2-F3 fibrosis at baseline: MRE ≥3.3 and <5 kPa
Measured: 6 months to 24 months follow-up period
Correlation between percent changes in imaging biomarkers for monitoring resmetirom treatment response over time.
Percent changes in UDFF and MRI-PDFF values from baseline to follow-up period and Percent changes in pSWE and MRE values from baseline to follow-up period.
Measured: 6 months to 24 months follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-steatohepatitis (MASH)Studies 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
- Prospective
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radnet Management, Inc.
- Sponsor type
- Research network
- Collaborators
- Madrigal Pharmaceuticals, Inc., Siemens Medical Solutions
- Responsible party
- Sponsor
- Investigators
- Randall Stenoien, MD, Principal investigator, RadNet Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860814
- Sponsor's protocol ID
- MSR-001
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy Using MRI as the Reference Standard
- ClinicalTrials.gov ID
- NCT07860814
- Acronym / sponsor ID
- MSR-001
- Keywords
- MASH, MASLD, UDFF, pSWE, MRI-PDFF, MRE, Madrigal, Siemens
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Radnet Management, Inc.Research network
- Collaborators
- Madrigal Pharmaceuticals, Inc., Siemens Medical Solutions
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 6 Oct 2026 (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 prospective, non-interventional, observational study to evaluate the accuracy of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness: UDFF (ultrasound-derived fat fraction) and pSWE (point shear wave elastography) for determining MRI-defined eligibility for resmetirom (REZDIFFRA®) treatment and for monitoring treatment response using MRI-PDFF (proton density fat fraction) and MRE (magnetic resonance elastography) as reference standards.
Study Centers Planned:
3 clinical practice facilities in Houston TX .
Study Rationale:
MASLD (metabolic dysfunction-associated steatotic liver disease ) is a growing global epidemic and the most common liver disease worldwide. Approximately 25% of adults in the United States alone have hepatic steatosis in the absence of significant alcohol consumption and 1 in 4 of these adults are presumed to have MASH.
MASH has a higher likelihood of progression to irreversible liver damage including cirrhosis and hepatocellular carcinoma.
Despite advancements in the field, there is still a high unmet need for technologies to accurately and reliably grade liver steatosis and stage liver fibrosis for applications related to patient identification and monitoring response to therapeutic intervention.
The association between hepatic steatosis and fibrosis progression underscores the need to have accurate and reliable noninvasive tools to aid in the assessment and monitoring of both liver steatosis and fibrosis.
The combination of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness (UDFF and pSWE) may aid clinicians in streamlining patient care pathways and potentially avoid unwanted and invasive medical intervention.
Detailed description
This study will consist of 3 phases:
- Technologist Training: Pre-study training will be conducted for all US (ultrasound) and MRI technologists to ensure standardized image acquisition across study sites.
- A Pilot Study will be conducted in healthy adult participants to qualify imaging centers to participate in the Main Study.
- The Main Study will be conducted in adult participants suspected of MASH (metabolic dysfunction-steatohepatitis) (with moderate to advanced fibrosis consistent with F2-F3 to evaluate the diagnostic performance of the combination of 2 US (ultrasound) biomarkers (UDFF and pSWE) for determining MRI-defined eligibility for resmetirom treatment and for monitoring treatment response over time .
A Pilot Study will be conducted before the Main Study to verify image acquisition quality and data completeness, and to assess repeatability (US) and reproducibility (US and MRI). The Pilot Study will include 24 adult participants (n=8 participants/site across 3 imaging centers).
Each participant in the pilot study will undergo 4 US (ultrasound) scans (2 scans each by 2 Certified US Technologists).
All US scans will be performed on SIEMENS ACUSON Sequoia systems using the 5C1 transducer and the same software version throughout the study. Repeated US scans will be separated by ≥5 minutes, with participants repositioned between scans by the Certified US Technologists.
Each participant in the pilot study will also undergo 2 MRI scans (1 scan each by 2 Certified MRI Technologists):
MR scans will be performed using either the SIEMENS MAGNETOM Skyra 3T or GE SIGNA PIONEER 3T, depending on scheduling and site availability. The MR scanner will be running the same software version throughout the study.
Data from participants in the Pilot Study will not be included in the analysis of the Main Study.
Data Quality Verification :
All pilot data will be reviewed by Siemens to verify image acquisition quality, completeness, and adherence to the imaging protocol.
Repeatability and reproducibility will be evaluated in the Pilot Study.
Main Study
Participants will be recruited from clinical practices in the Houston, Texas area by hepatologists, gastroenterologists, and other referring clinicians. US (ultrasound) and MRI examinations will be performed across 3 Sponsor imaging centers in the Houston area. All participants will undergo Baseline US (ultrasound) biomarkers (UDFF, pSWE) and MRI biomarkers (MRI-PDFF, MRE) on the same day.
Blinding
- Referring physicians will be blinded to US (ultrasound) (UDFF and pSWE) results, and thus decisions to prescribe resmetirom will be made based solely on MRI biomarkers (ie, MRI-PDFF and MRE) and clinical assessment.
- US (ultrasound) operators will be blinded to results from MRI biomarkers (MRI-PDFF and MRE).
- MRI operators will be blinded to results from US (ultrasound) biomarkers (UDFF and pSWE).
Duration of Study Participation
- Pilot Study: 1 day, in addition to the Screening Visit
- Main Study :
- Participants NOT treated with resmetirom: Screening(consenting)and day 1 baseline MRI and US(2 visits total);
- Participants treated with resmetirom (prescribed by their referring physician based on Baseline MRI results and clinical assessment): Screening (consenting), day 1 baseline MRI and US then at months 6, 12 and 24 (5 visits total).
Study Assessments
- Record demographics
- Record medication history since last visit
- Record laboratory test results since last visit
- Perform US (ultrasound)
- Perform MRI
- Record/report SAEs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must be fully informed of the potential benefits of approved products and make an informed decision that they prefer to participate in a clinical study. Regulatory, ethical, and study oversight considerations are provided in the protocol. Participants will be recruited from clinical practices in the Houston, Texas area by hepatologists, gastroenterologists, and other referring clinicians. * Participants in the Pilot Study will be healthy adult males or females, age ≥18 years. * Participants in the Main Study will be adult males or females, age ≥18 years, suspected of MASH with moderate to advanced fibrosis consistent with F2-F3. Participants will be eligible if they meet ALL inclusion criteria and NONE of the exclusion criteria at Screening.
Key inclusion criteria (4 listed)
- Participants must meet the following criteria:
- Healthy adults (≥18 years) with no known liver diseases
- Participants must meet the following criteria:
- Adults (≥18 years) suspected of MASH with moderate to advanced fibrosis consistent with F2-F3 with no other known liver disease
Key exclusion criteria (4 listed)
- Use of steatogenic or hepatotoxic medications (eg, corticosteroids such as prednisone, amiodarone, methotrexate, tamoxifen)
- Contraindications to MRI
- Pregnancy
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
Diagnostic performance of UDFF (ultrasound-derived fat fraction)
Time frame: Enrollment Day 1 Baseline
Ultrasound criteria associated with elevated liver fat at baseline: UDFF ≥8%
Diagnostic performance of Ultrasound pSWE (point shear wave elastography)
Time frame: Enrollment Day 1 Baseline
Ultrasound criteria consistent with MASH F2-F3 fibrosis at baseline: pSWE ≥7 and <17 kPa
5 secondary outcomes
The accuracy of the Ultrasound biomarker pSWE (point shear wave elastography) for monitoring resmetirom treatment response over time.
Time frame: 6 months to 24 months of follow-up period
The accuracy of the Ultrasound biomarker UDFF (ultrasound-derived fat fraction) for monitoring resmetirom treatment response over time.
Time frame: 6 months to 24 months of follow-up period
Corresponding percent changes in MRI-PDFF (proton density fat fraction) from baseline to follow- up period are tested for statistical equivalence
Time frame: 6 months to 24 months follow-up period
Corresponding percent changes in MRE (magnetic resonance elastography) from baseline to followup period are tested for statistical equivalence
Time frame: 6 months to 24 months follow-up period
Correlation between percent changes in imaging biomarkers for monitoring resmetirom treatment response over time.
Time frame: 6 months to 24 months follow-up period
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 6 Oct 2026.
- 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.
Randall Stenoien, MD principal investigator
RadNet Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-steatohepatitis (MASH), run by Radnet Management, Inc. at 3 sites 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 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Senior Vice President of Research (+1 562-981-6101, Kristi.Maya@radnet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of UDFF (ultrasound-derived fat fraction) (time frame: Enrollment Day 1 Baseline). 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 6 Oct 2026.