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Идёт набор NCT07270601

Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Без фазы С лечением MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease NAFLD - Non-Alcoholic Fatty Liver Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan, Philips 3T Ingenia Elition.
Кому может быть актуально
Состояния в реестре: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )

Обзор

The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. If successful, this ultrasound tool could become an easier and more accessible way to monitor liver health - especially for people with obesity, diabetes, high blood pressure, or high cholesterol.

Подробное описание

The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.

Вмешательства

  • Устройство Verasonics NXT Data Acquisition System
    A research ultrasound imaging device to capture raw radiofrequency ultrasound data for the following parameters: * B-mode imaging * Attenuation coefficient * Backscatter coefficient * Speed of sound * Shear wave elastography
  • Устройство Philips EPIQ Elite
    A premium ultrasound system with software package to support imaging research studies.
  • Устройство EchoSense FibroScan
    A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
  • Устройство Philips 3T Ingenia Elition
    A 3-tesla magnetic resonance imaging (MRI) system

Первичные конечные точки

  • Multiparametric Ultrasound Biomarker vs. MR-PDFF [Срок оценки: 1 year]
Вторичные конечные точки (2)
  • Individual Ultrasound parameter vs. MRI-PDFF [Срок оценки: 1 year]
  • Ultrasound Shear Wave vs MR Elastography [Срок оценки: 1 year]

Критерии участия

Критерии включения

Diseased subject:

  • Adult patients (age 18 - 75 years)
  • Consent to participate in the study
  • Diagnosed or suspected MASLD from the hepatology clinic, OR
  • High-risk population meeting the adult cardiometabolic criteria (defined as the presence of at least one of the following: diabetes, obesity (BMI ≥ 25 kg/m2), hypercholesterolemia, and hypertension)

Healthy volunteer:

  • Adult patients (age 18 - 75 years)
  • Consent to participate in the study
  • No suspicion of MASLD by laboratory/imaging/clinical examinations
  • Absence of known pre-existing conditions (metabolic syndrome, diabetes mellitus, obesity, insulin resistance, dyslipidemia, etc.)

Критерии исключения

  • Pregnancy or nursing.
  • Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s).
  • Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions.
  • BMI > 35 kg/m2
  • History of excessive alcohol consumption according to the updated MASLD criteria (>2 drinks/day OR >210 grams/week for males AND >1 drink/day OR >140 grams/week for females) or drug use over the past 2 years.
  • Known acute or chronic hepatitis; or other etiology of liver disease.
  • Presence of known congenital hepatic anomaly.
  • Known cirrhosis
  • Known active cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • University of Washington — Seattle

Идентификаторы

NCT: NCT07270601 · COV-POCUS-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗