The COherence of Scatter Identification and Exclusion Algorithm Study
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Ultrasound image processing.
- Кому может быть актуально
- Состояния в реестре: Steatohepatitis, Nonalcoholic. Базовые параметры: от 18 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
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study
Обзор
Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver condition worldwide; approximately 55% of the world population will have NAFLD by 2040. NAFLD is an unwanted side effect of common cancer therapies, such as chemotherapy. Ultrasound can detect NAFLD via measurement of the backscatter coefficient (BSC). It is an attractive technique because of its low cost and availability, potentially enabling earlier detection of NAFLD in a larger population through screening. This approach has shown promise in detecting NAFLD but is limited by variability in measurement due to several factors. Measurement of the BSC requires assumptions about the nature of the tissue being measured; if these assumptions are incorrect, they can lead to inaccurate BSC measurements. To improve accuracy, an algorithm (COSIE) was developed to quantify the suitability of tissue for BSC analysis. The investigators believe COSIE will enable more reliable BSC measurements by selecting the optimal regions of tissue to measure. By measuring the BSC in the livers of healthy volunteers and patients with evidence of fatty liver, the algorithm can be evaluated against liver fat percentage values obtained from MRI imaging. This study will assess whether applying the COSIE algorithm enhances the reliability of BSC measurements, bringing them closer in quality to MRI imaging.
Вмешательства
- Устройство Ultrasound image processing
The COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient.
Первичные конечные точки
- Difference in backscatter coefficient [Срок оценки: up to 6 months]
Критерии участия
Критерии включения
Healthy Volunteers:
- Healthy male or female adults (18 or above).
- Volunteers must consider themselves fit and healthy.
- RMH and/or ICR employees.
Patients:
- Patients undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI.
- Aged 18 and above.
Критерии исключения
Healthy Volunteers:
- Volunteers that are under investigation or planning to consult their GP to seek investigation for an undiagnosed condition, particularly regarding pelvic or abdominal disease or injury.
- Healthy volunteers who do not have an NHS number or who are not registered with a GP will be excluded.
Patients:
- Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 1 центр
- The Royal Marsden Hospital — London
Идентификаторы
NCT: NCT06975579 · CCR 5912 · 24/NW/0086