Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal
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: CPMX1.
- Кому может быть актуально
- Состояния в реестре: Thyroid Nodule (Diagnosis). 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
- Швейцария
- 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
Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal (CPMX-Thyr)
Обзор
The thyroid gland plays an important role in hormone regulation however, it is often prone to nodules. This is common with nodules being found in up to 68% of people in a neck ultrasound, with likelihood increasing with age. However, only about 1 in 20 nodules turns out to be cancerous. Diagnosis of thyroid nodules starts with ultrasonic assessment, where specific features have been identified to estimate the risk of malignancy. If further examination is recommended, Fine Needle Aspiration (FNA) is performed. A needle is inserted into the nodule and the obtained subset of cells are then classified into 6 categories (Bethesda score) after examination under the microscope. While some Bethesda scores provide very accurate malignancy predictions, others like category 4, are unspecific, with risk of malignancy ranging from 25 to 40%. For these patients, about 75% are operated on even though they are not prospectively diagnosed. Soft tissue has certain physical properties, including its compressibility, which could be quantified by measuring the pressure required to deform it. It has been found that cancerous tissue is often harder than the surrounding healthy tissue. Compremium, a Swiss company which has its headquarters in Muri bei Bern, has developed a device that can be used to measure the compressibility of tissue, similarly to palpation but providing a quantitative assessment. The present study aims to investigate the feasibility and preliminary efficacy of this new technology to predict if thyroid nodules of patients scheduled for surgical removal based on FNA analysis are malignant or not.
Вмешательства
- Устройство CPMX1
Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit
Первичные конечные точки
- Device safety [Срок оценки: up to 6 months]
- Device safety [Срок оценки: Up to 6 months]
- Device safety [Срок оценки: Up to 6 months]
Вторичные конечные точки (1)
- Preliminary efficacy of CPMX1 compressability values to predict thyroid nodule malignancy. [Срок оценки: 60 minutes]
Критерии участия
Критерии включения
- Patients older than 18 years
- Patients with a thyroid node
- Patients with a Bethesda IV cytopathological diagnosis of this node
- Informed consent documented by signature
Критерии исключения
- Non-intact skin at the measurement site
- BMI>35kg/m2
- Patients unable to provide informed consent
- Pregnant or breastfeeding women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Швейцария · 1 центр
- Department of Oto-Rhino-Laryngology, Head and Neck surgery Inselspital, Bern University Ho — Bern
Идентификаторы
NCT: NCT07102264 · CPMX-Thyr