Detection of sentinel lymph nodes in female lower genital tract cancer patients with contrast-enhanced ultrasound imaging

女性下生殖道癌（宫颈癌、阴道癌或外阴癌）每年影响约25 000名妇女， 在美国，死亡率为27%，每年约有6,700名妇女死亡。治疗方法各不相同 根据疾病的阶段。疾病的早期阶段（I期）用外科手术治疗。 在手术前，患者接受PET-CT以确定淋巴结（LN） 转移浸润，以确定手术LN剥离的必要性。然而，大多数妇女 被诊断为晚期疾病（2、3或4期），其中选择的治疗是化疗 和/或放疗，使用PET-CT确定治疗前和治疗后的LN转移浸润。 淋巴结中亚临床恶性肿瘤的检测在宫颈、阴道和外阴的治疗中非常重要 癌症，因为这是肿瘤分期的一部分，用于预测和治疗。最 要评估的重要LN是前哨LN（SLN），第一个接受输入淋巴引流的LN， 淋巴管（LC）从肿瘤。已经开发了各种技术和成像剂 绘制肿瘤的淋巴引流，包括注射蓝色染料、吲哚菁绿色和注射 放射性药物（放射性同位素）。超声造影是一种成熟的技术， 全球范围内的各种血管应用。我们的团队和其他人已经证明，SLN可以 在肿瘤周围注射超声造影剂（UCA）后，由于摄取， 通过LC和网状内皮系统（称为“淋巴超声检查”）。注射后，迁移 可以通过LC对SLN进行真实的实时可视化。这项研究将比较使用 淋巴超声检查用于SLN检测，符合护理标准淋巴映射，具体取决于 患者分期（淋巴结清扫和/或连续PET-CT）。因此，这一理论的科学前提 淋巴超声检查可用于识别宫颈、阴道或外阴癌患者的前哨淋巴结。 成功率高于标准治疗的癌症。本项目的患者人群将反映 美国主要城市学术健康中心的人口统计数据。总体TJUH 人口统计学数据包括60%的高加索人、16%的非裔美国人、13%的西班牙人、5%的亚洲人、1%的其他人， 还有5%的未知患者。目标是在2年内招募40名患者参加这项初步研究。受试者 被招募的人将接受他们的标准护理治疗。此外，他们将接受淋巴超声检查 其中，所有显示对比度增强的LN都将被视为SLN，并且结果将是 记录并与护理标准进行比较。

Female lower genital tract cancer (cervical, vaginal or vulvar) affect approximately 25,000 women yearly in the United States with a mortality rate of 27% or about 6,700 women yearly. The treatment approach varies according to the stage of the disease. Early stages of disease (stage I) are treated with surgical intervention, and prior to the surgery the patients undergo PET-CT to determine lymph node (LN) metastatic infiltration to determine the necessity of surgical LN dissection. However, the majority of women are diagnosed with advanced disease (stages 2, 3 or 4), where the treatment of choice is chemotherapy and/or radiotherapy, with the use of PET-CT to determine LN metastatic infiltration pre- and post-treatment. Detection of subclinical malignancy in LNs is important in the management of cervical, vaginal and vulvar cancers, since this is part of tumor staging which is used to base both prognosis and therapy. The most important LN to evaluate is the sentinel LN (SLN), the first LN to receive afferent lymphatic drainage through lymphatic channels (LCs) from the tumor. Various techniques and imaging agents have been developed to map lymphatic drainage from tumors, including injection of blue dye, indocyanine green and injection of radiopharmaceuticals (radioisotopes). Contrast-enhanced ultrasound is a well-established technique for a variety of vascular applications worldwide. Our group and others have demonstrated that SLNs can be detected with CEUS following peri-tumoral injections of ultrasound contrast agents (UCA), due to uptake by the LCs and the reticuloendothelial system (termed “lymphosonography”). Following injection, migration of the agent can be visualized through the LCs to the SLNs in real time. This study will compare the use of lymphosonography for SLN detection to the standard of care lymphatic mapping that varies depending on the patient's staging (lymph node dissection and/or sequential PET-CT). Thus, the scientific premise of this project is that lymphosonography can be used to identify SLNs in patients with cervical, vaginal or vulvar cancers with better success rates than the standard of care. The patient population of this project will reflect the population demographics found at major American urban academic health centers. The overall TJUH demographics include 60 % Caucasian, 16 % African American, 13 % Hispanic, 5 % Asian, 1 % Other, and 5 % unknown patients. The goal is to enroll 40 patients over 2 years into this pilot study. The subjects recruited will receive their standard of care treatment. Additionally, they will undergo lymphosonography where all LNs that demonstrate contrast-enhancement will be considered SLNs and the results will be recorded and compared with the standard of care.