Axillary LNs Evalution in Breast Cancer by Multimodal Us
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: multi modal Us.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Lymph Node Metastasis. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- 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
"Axillary Nodal Evaluation in Breast Cancer by Multimodal US"
Обзор
The present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. It aims to compare the diagnostic indices of each modality individually against their combined performance. Specifically, the study will assess whether adding UE to conventional gray-scale US and CDU improves diagnostic accuracy.
Подробное описание
Breast cancer (BrCa) is the most common malignant tumor affecting women globally, with its incidence and cancer-related mortality rates continuing to rise. Accurate evaluation of the presence, extent, and status of ALNs is critical for prognosis, disease staging, and treatment planning in patients with breast cancer.
Historically, axillary lymph node dissection (ALND), followed by histopathological evaluation, was the standard method for staging breast cancer. However, ALND is associated with short- and long-term complications such as lymphedema, nerve injury, seroma formation, and infection. To reduce these risks, sentinel lymph node biopsy (SLNB) has largely replaced ALND. While SLNB is less invasive and has fewer complications, it is still associated with a risk of false-negative results. According to the American Society of Oncology Guidelines, if SLNB results are negative, no further ALND is performed, as it does not confer a survival benefit. Patients with positive SLNB results, however, undergo a "completion" ALND.
Role of Ultrasound and Color Doppler Ultrasound:
Gray-scale ultrasound (US) is a non-invasive imaging modality widely used for the preoperative evaluation of ALNs in breast cancer patients. It provides valuable morphological information and facilitates obtaining tissue samples. However, its diagnostic accuracy is operator-dependent and limited to structural features of the lymph nodes. Adding Color Doppler Ultrasound (CDU) enhances this evaluation by providing functional insights, such as assessing vascular patterns and calculating the resistive index (RI) of ALNs. Despite their potential, US and CDU exhibit highly variable sensitivity and specificity across studies, which limits their standalone diagnostic utility.
Role of Ultrasound Elastography (UE):
Real-time strain ultrasound elastography (UE) is an advanced imaging technique that measures tissue stiffness, a property often associated with malignancy. Unlike US and CDU, UE can quantify stiffness, providing additional diagnostic insights. Elastography utilizes rhythmic manual compression to produce color-coded elastograms, which display differences in tissue stiffness. These elastograms are generated alongside conventional gray-scale US to ensure precise imaging of the same lymph node. Although UE has been explored for ALN assessment, existing studies report inconsistent results.
Recent meta-analyses suggest that UE offers valuable supplementary information for preoperative ALN evaluation and may influence surgical decision-making.
Other Imaging Modalities:
Alternative imaging techniques, including mammography, magnetic resonance imaging (MRI), multi-detector computed tomography (CT), and positron-emission tomography (PET-CT), have also been employed for ALN assessment. However, their widespread application is limited by moderate sensitivity, low specificity, high costs, radiation exposure, and the need for specialized imaging protocols for ALNs.
Multimodal Imaging:
Multimodal imaging, which combines two or more imaging techniques, provides a more comprehensive diagnostic approach than individual modalities alone. This study investigates the combined use of gray-scale US, CDU, and UE to improve diagnostic accuracy for ALN assessment in breast cancer patients.
This version addresses the study's purpose, methodology, and the role of each modality in greater detail
Вмешательства
- Устройство multi modal Us
Greyscale US: grey scale ultrasound Color Doppler US: Color Doppler ultrasound Elastography US: Elastography ultrasound
Первичные конечные точки
- Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound [Срок оценки: Baseline]
- Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound [Срок оценки: Baseline]
- Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound [Срок оценки: Baseline]
- Comparison of Multimodal Ultrasound Findings with Histopathology Results [Срок оценки: Baseline]
Критерии участия
Критерии включения
\- Patients with primary breast cancer (BrCa) and axillary lymph nodes (ALNs) referred to the Department of Diagnostic Radiology for pre-operative assessment of presence, extent and nature of ALNs.
Критерии исключения
- Patients with secondary or recurrent Breast Ca
- Patients exposed to loco-regional radio- or chemotherapy
- Patients with previous axilla surgery
- ± Patients with confirmed metastatic tumor to bone, liver and/or lungs
- Patients who deny or refuse to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Tsai WC, Lin CK, Wei HK, Yu BL, Hung CF, Cheng SH, Chen CM. Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer: a prospective study. Ultrasound Med Biol. 2013 Jun;39(6):941-9. doi: 10.1016/j.ultrasmedbio.2012.12.013. Epub 2013 Mar 7. PMID 23465139
- DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2. PMID 31577379
Идентификаторы
NCT: NCT06695052 · Axillary LNs in BC by multi US