Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

Обзор

This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI. The investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices. Our goals are: * To assess the accuracy of the advanced ultrasound analysis techniques in children * To implement and assess these advanced technique on small handheld ultrasound devices, if possible

Подробное описание

Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.

Our study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.

Вмешательства

• Диагностический тест MR exam
  Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
• Диагностический тест US exam
  Participants will undergo an abdominal ultrasound (US) examination using a full-size US system. Some participants may undergo a point-of-care abdominal US exam with a handheld US system, if possible.
• Другое Blood draw
  Participants will undergo a blood draw of approximately 25 mL volume.
• Другое Physical measurements
  Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.
• Другое Questionnaires
  Participants will be asked to fill out questionnaires to collect information about their prescribed medications, demographics, medical and surgical histories, prior laboratory results, physical activity and lifestyle measures, and potential alcohol intake (AUDIT questionnaire).

Первичные конечные точки

• Development and Evaluation of models for liver fat estimation. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age 9 to 18 years
• Presence of risk factors for having MASLD
• Ability and willingness of participant or legal guardian/parent to give written informed consent
• Participant is willing to give written assent
• Able and willing to undergo all study procedures

Критерии исключения

• Known liver disease other than MASLD
• Pregnant or trying to become pregnant
• Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference > 140 cm, claustrophobie, and/or metal implants.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of California San Diego — La Jolla

Идентификаторы

NCT: NCT06706856 · 809669 · 1R01DK135951-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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