Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer

The early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors. Accurately understanding the status of axillary lymph nodes prior to surgery allows better prediction of staging, enables correct treatment plans, and guides the scope of node dissection during surgery. For patients with early breast cancer or clinically negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper extremity lymphedema caused by axillary lymph node dissection (ALND). Thus, clinical identification of negative lymph nodes becomes more valuable. Based on clinical verification, the NCCN guidelines (edition 2019) made the following recommendation: SLNB is performed for patients with clinically negative axillary lymph nodes, and the biopsy findings determine whether ALND is included; ALND is performed for patients with clinically positive axillary nodes. Currently, imaging examinations have limitations is assessing axillary lymph nodes. Finding an accurate and non-invasive method in preoperative axillary assessment has been a project that needs to be urgently addressed. Ultrasonography has advantages in its simplicity, non-invasiveness, economy, and on radiation, however it is highly subjective, dependent upon examiner's experience and knowledge, and is difficult to detect deeper and small lesions. Molybdenum Target examination plays an important role in diagnosis of breast cancer, however it is expensive and limited in evaluating the whole axilla. PET-CT is restricted by its high cost and is not a routine examination in China. Therefore, computed tomography (CT) scan is more advantageous in determination of lymph node metastasis. The 2014 GORO KUTOMI study suggested that lymph node morphology assessed as clear by preoperative CT was an independent predictor of sentinel lymph node metastasis. CT scan can not only evaluate the presence or absence of distant metastasis and pectoralis muscle invasion, but also provide intuitive, accurate and detailed evaluation of axillary, supraclavicular, and pectoralis major intramuscular lymph nodes. The diagnostic criteria of magnetic resonance imaging (MRI) is relatively vague; CT can also obtain imaging data of the lungs, mediastinum, whereas MRI has no such function. Based on previous studies, we will further explore and evaluate axillary node status using prone positioning CT scan and ultrasound in patients with breast cancer.

NCT Number	NCT05346510
Lead Sponsor	Shengjing Hospital
Conditions	Breast Cancer
Enrollment	500 participants
Start Date	2022-03-01
Primary Completion	2022-09-01 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2022-04-26