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Набор по приглашению NCT06463223

HIBOC = Hepatic Imaging Biomarkers in Obese Children

Наблюдательное Elastography Shear Wave Elastography Shear Wave Dispersion Attenuation Imaging

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Elastography, Shear Wave Elastography, Shear Wave Dispersion, Attenuation Imaging. Базовые параметры: 9 лет — 14 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study

Обзор

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

Подробное описание

Background Childhood obesity is a global health problem with a prevalence of 10%. Overweight and obesity are strongly associated with metabolic-associated fatty liver disease (MASLD), which includes a continuum of fatty liver, hepatitis, fibrosis, and cancer. Early diagnosis is crucial for reducing morbidity and mortality but requires detailed characterization of the liver, for which invasive biopsies are the gold standard.

New ultrasound-based markers are promising, non-invasive methods for liver characterization; Shear Wave Dispersion (SWD), Shear Wave Elastography (SWE), and Attenuation Imaging (ATI) have been reported as promising for reflecting inflammation, fibrosis, and steatosis in the liver, respectively. Clinical studies are needed to validate the usefulness of these markers, particularly in children.

Purpose The study aims to determine whether imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measures, and treatment effects over time.

Material \& Method This study is a prospective diagnostic observational study, including children (approximately 300) referred for obesity to several Pediatric Clinics in Västra Götaland, Sweden. Inclusion criteria are: age 9-14 years, BMI \> 29, obesity \> 1 year. Exclusion criteria: comorbidity that can affect the liver. Ultrasound with measurements of the livermarkers SWE, SWD, and ATI will be performed at inclusion and during annual visits over 3 years. SWE, SWD, and ATI will be compared with parameters included in clinical monitoring, such as weight, height, BMI, blood tests, blood pressure, waist circumference, physical activity, screen habits, etc. In a subcohort, estimated 50 children, with obesity-related disease as indication for referral and treatment to Queen Silvias Childrens Hospital, additionally MRI will be performed at inclusion.

Significance Imaging-based liver markers have great potential to improve diagnostics in children with obesity by reflecting liver disease without a biopsy. If these markers can be used to early diagnose liver disease before it becomes manifest, it is a significant gain. Additionally, if it is possible to distinguish between different pathoanatomical phenotypes (fibrosis/inflammation/steatosis) without a biopsy, it is possible to monitor the disease more rigorously, which opens new opportunities to optimize treatment for the individual child.

Первичные конечные точки

  • Attenuation imaging [Срок оценки: baseline, 1 year, 2 years and 3 years follow up]
  • Shear wave dispersion [Срок оценки: baseline, 1 year, 2 years and 3 years follow up]
  • shear wave dispersion [Срок оценки: baseline, 1 year, 2 years and 3 years follow up]
Вторичные конечные точки (4)
  • Magnetic Resonance Imaging fat fraction [Срок оценки: baseline, 1 year, 2 years and 3 years follow up]
  • Magnetic Resonance Imaging elastography [Срок оценки: Baseline, 1 year,2 years and 3 years follow up]
  • Magnetic Resonance Imaging diffusionbased imaging [Срок оценки: baseline, 1 year, 2 years and 3 years follow up]
  • Magnetic Resonance Imaging relaxometry [Срок оценки: Baseline, 1 year,2 years and 3 years follow up]

Критерии участия

Критерии включения

  • Age 9 to 14 years
  • New referral/first visit or follow-up annual visit at each healthcare center (Child and adolescent oriented centers) included
  • BMI 30 or more
  • Obesity >1 year at inclusion

Критерии исключения

  • Difficulty understanding written/oral information
  • Comorbidities that can affect the liver (e.g., medications or diseases with known liver impact)
  • Claustrophobia (applies to the MRI cohort)
  • Implants or other factors that prevent MRI (applies to the MRI cohort)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Швеция · 1 центр
  • Department of Radiology, Queen Silvias Children´s Hospital, Institution of Clinical Scienc — Gothenburg

Идентификаторы

NCT: NCT06463223 · 2024-02255-01

Первоисточники (государственные реестры)

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