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Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy

2026年9月30日 更新者：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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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

研究の種類

観察的

入学 (推定)

524

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Senior Vice President of Research
  • 電話番号：+1 562-981-6101
  • メール：Kristi.Maya@radnet.com

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Texas
      • Houston、Texas、アメリカ、77055
        • HMI/Campbell
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Randall Stenoien, MD
      • Houston、Texas、アメリカ、77079
        • HMI/Energy Corridor
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Randall Stenoien, MD
      • Pearland、Texas、アメリカ、77581
        • HMI/Pearland
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Randall Stenoien, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diagnostic performance of UDFF (ultrasound-derived fat fraction)
時間枠：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)
時間枠：Enrollment Day 1 Baseline

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

二次結果の測定

結果測定
メジャーの説明
時間枠
The accuracy of the Ultrasound biomarker pSWE (point shear wave elastography) for monitoring resmetirom treatment response over time.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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.
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
To evaluate factors influencing imaging biomarkers MRI-PDFF, MRE, UDFF and pSWE.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Radnet Management, Inc.

協力者

Siemens Medical Solutions
Madrigal Pharmaceuticals, Inc.

捜査官

  • 主任研究者：Randall Stenoien, MD、RadNet Research

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2030年10月1日

試験登録日

最初に提出

2026年8月31日

QC基準を満たした最初の提出物

2026年9月30日

最初の投稿 (実際)

2026年10月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年9月30日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MSR-001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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