Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
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: Ultrasound Imaging 3D and Spectroscopy.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Breast Masses. Базовые параметры: Без ограничений · 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
- Канада
- 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
Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
Обзор
The purpose of the study is to test the hypothesis that quantitative ultrasound techniques including spectroscopy may be used as a non-invasive biomarker for characterization of suspected breast cancers. The main goal is to select and identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize suspected breast cancers, as identified based on the histopathology reports on core biopsy specimens, surgery reports, or radiology reports. Primary endpoint will correlate quantitative ultrasound parameters to the histopathological properties, as determined from pathology reports on core biopsy specimens, surgery reports, or radiology reports. The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.
Подробное описание
This project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. Patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. Results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.
Вмешательства
- Устройство Ultrasound Imaging 3D and Spectroscopy
Ultrasound imaging and spectroscopy will consist of collecting three dimensional data. Regions of interest in each of the tumour images and in the adjacent normal tissue will be selected for analysis.
Первичные конечные точки
- Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues. [Срок оценки: Up to 2 years]
Вторичные конечные точки (1)
- Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes. [Срок оценки: Up to 5 years]
Критерии участия
Критерии включения
- Women or men with suspected breast cancer
- Patients should have the ability to understand and the willingness to sign a written informed consent document.
Критерии исключения
- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
- Receiving any other investigational agents.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Канада · 1 центр
- Sunnybrook Health Sciences Centre — Toronto
Идентификаторы
NCT: NCT06175078 · 5587