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

年，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。 美国的死亡率为27%，即每年约有6700名妇女。治疗方法各有不同 根据疾病的不同阶段进行分类。疾病的早期(I期)用外科手术治疗。 干预，患者在手术前接受PET-CT以确定淋巴结(LN)。 转移性浸润以确定手术切除LN的必要性。然而，大多数女性 被诊断为晚期疾病(2、3或4期)，选择的治疗方法是化疗 和/或放射治疗，治疗前后用PET-CT判断LN的转移浸润情况。 在宫颈、阴道和外阴的治疗中，发现淋巴结的亚临床恶性是重要的。 癌症，因为这是肿瘤分期的一部分，用来作为预后和治疗的基础。最多的 要评估的重要LN是前哨LN(SLN)，它是第一个接受传入淋巴引流的LN 肿瘤的淋巴通道(LC)。已经开发了各种技术和显像剂 绘制肿瘤淋巴引流图，包括注射蓝色染料、吲哚青绿和注射 放射性药品(放射性同位素)。对比增强超声是一种成熟的技术，可用于 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了SLN可以 肿瘤周围注射超声造影剂(UCA)后的CEUS检测，由于摄取 通过LCS和网状内皮系统(称为“淋巴超声”)。注射后，迁移 可以通过LCS实时可视化到SLN。这项研究将比较 淋巴超声检测SLN的标准取决于不同的淋巴标测 患者的分期(淋巴清扫和/或序贯PET-CT)。因此，这一点的科学前提 项目是淋巴超声可以用来识别患有宫颈、阴道或外阴的SLN患者。 癌症的成功率高于护理标准。该项目的患者人数将反映 美国主要城市学术健康中心的人口统计数据。TJUH的总体情况 人口结构包括60%的高加索人，16%的非裔美国人，13%的西班牙裔，5%的亚洲人，1%的其他人， 5%的患者身份不明。目标是在两年内招募40名患者参加这项先导性研究。主题 被招募的人将得到他们标准的护理待遇。此外，他们还将接受淋巴超声检查。 所有显示对比度增强的淋巴结都将被视为SLN，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.