跳至主要内容
临床试验/NCT05346510
NCT05346510招募中不适用

Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Agreement rates with postoperative histology

研究概览

简要总结

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.

详细描述

A total of 500 patients who are newly diagnosed with operable breast cancer in Liaoning Oncology Hospital are approached and recruited. Inclusion criteria: 1. preoperative chest CT and axillary Doppler ultrasound examination in the prone position; 2. perform ALND; 3. regular follow-up post surgery, short-term and long-term. Exclusion criteria: history of other benign or malignant tumors causing axillary lymphadenopathy.

Comparisons are made:

A: between suspiciously positive and suspiciously negative axillary lymph nodes B: between LNSD positive among suspiciously positive axillary lymph nodes and negative axillary lymph nodes f C: between positive and negative AAUS D: between positive and negative AAUS among negative lymph nodes detected by CT scan E: between positive and negative AAUS among lymph nodes with negative LNSD

Chi-square test and t test are used to assess statistical significance between groups.

Methods: Lymph node short diameter (LNSD) is measured using CT scan imaging (LNSD > 1cm is considered positive), axillary lymph node status is assessed according to axillary lymph node Doppler ultrasound. ALND will be performed in patients with positive axillary lymph nodes on CT scan; PALND will be performed for those with negative axillary lymph nodes on CT scan but positive on AAUS; SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Preoperative chest CT and axillary Doppler ultrasound examination in the prone position
  • Perform ALND
  • Regular post surgery follow-up (short-term and long-term)

排除标准

  • History of other benign or malignant tumors causing axillary lymphadenopathy

结局指标

主要结局

Agreement rates with postoperative histology

时间窗: Two weeks

The accuracy of CT scan detecting positive axillary lymph node and positive AAUS is assessed by the postoperative histology results

次要结局

  • The incidence of postoperative lymphedema (short-term observational indicator)(Two years)
  • Axillary recurrence rate(Five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianyi Li

Principal Investigator

Shengjing Hospital

研究点 (1)

Loading locations...

相似试验