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、阴道或外阴）每年影响约25,000名妇女

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.