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Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy

30 september 2026 uppdaterad av: Radnet Management, Inc.

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:

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

This study will consist of 3 phases:

  1. Technologist Training: Pre-study training will be conducted for all US (ultrasound) and MRI technologists to ensure standardized image acquisition across study sites.
  2. A Pilot Study will be conducted in healthy adult participants to qualify imaging centers to participate in the Main Study.
  3. 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

Studietyp

Observationell

Inskrivning (Beräknad)

524

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77055
        • HMI/Campbell
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Randall Stenoien, MD
      • Houston, Texas, Förenta staterna, 77079
        • HMI/Energy Corridor
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Randall Stenoien, MD
      • Pearland, Texas, Förenta staterna, 77581
        • HMI/Pearland
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Randall Stenoien, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Enrollment Criteria

Participants will be recruited from clinical practices in the Houston, Texas area by hepatologists, gastroenterologists, and other referring clinicians.

Inclusion Criteria (Pilot Study):

  • Participants must meet the following criteria:
  • Healthy adults (≥18 years) with no known liver diseases

Inclusion Criteria (Main Study):

  • 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

Exclusion Criteria (Pilot Study, Main Study):

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic performance of UDFF (ultrasound-derived fat fraction)
Tidsram: Enrollment Day 1 Baseline

Ultrasound criteria associated with elevated liver fat at baseline: UDFF ≥8%
Enrollment Day 1 Baseline
Diagnostic performance of Ultrasound pSWE (point shear wave elastography)
Tidsram: Enrollment Day 1 Baseline

Ultrasound criteria consistent with MASH F2-F3 fibrosis at baseline: pSWE ≥7 and <17 kPa
Enrollment Day 1 Baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The accuracy of the Ultrasound biomarker pSWE (point shear wave elastography) for monitoring resmetirom treatment response over time.
Tidsram: 6 months to 24 months of follow-up period

Percent changes in Ultrasound pSWE from baseline to follow-up period are tested for statistical equivalence.
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.
Tidsram: 6 months to 24 months of follow-up period

Percent changes in UDFF from baseline to follow-up period are tested for statistical equivalence
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
Tidsram: 6 months to 24 months follow-up period

MR criteria associated with elevated liver fat at baseline: PDFF ≥8%
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
Tidsram: 6 months to 24 months follow-up period

MR criteria consistent with MASH F2-F3 fibrosis at baseline: MRE ≥3.3 and <5 kPa
6 months to 24 months follow-up period
Correlation between percent changes in imaging biomarkers for monitoring resmetirom treatment response over time.
Tidsram: 6 months to 24 months follow-up period

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.
6 months to 24 months follow-up period

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
Tidsram: Enrollment Day 1 Baseline to 24 months follow-up period

• Assessment of the influence of GLP-1 therapy use using a subgroup analysis.
Enrollment Day 1 Baseline to 24 months follow-up period
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
Tidsram: Enrollment Day 1 Baseline to 24 months followup period

• Assessment of the influence of weight change using a subgroup analysis.
Enrollment Day 1 Baseline to 24 months followup period
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
Tidsram: Enrollment Day 1 Baseline to 24 months follow-up period

• Assessment of the association of BMI
Enrollment Day 1 Baseline to 24 months follow-up period
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
Tidsram: Enrollment Day 1 Baseline to 24 months follow-up period.

• Assessment of the association of MR-R2 (speed of signal delay)
Enrollment Day 1 Baseline to 24 months follow-up period.
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
Tidsram: Enrollment Day 1 Baseline to 24 months follow-up period

Assessment of association of laboratory findings
Enrollment Day 1 Baseline to 24 months follow-up period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Radnet Management, Inc.

Samarbetspartners

Siemens Medical Solutions
Madrigal Pharmaceuticals, Inc.

Utredare

  • Huvudutredare: Randall Stenoien, MD, RadNet Research

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2028

Avslutad studie (Beräknad)

1 oktober 2030

Studieregistreringsdatum

Först inskickad

31 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

30 september 2026

Första postat (Faktisk)

6 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MSR-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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