Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Bilateral SLNs
研究概览
简要总结
The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.
详细描述
Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green.
Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient has histological diagnosis of cancer of the endometrium of any histology or grade.
- •The patient should have received no prior treatment for her endometrial cancer.
- •The patient has clinically uterine confined disease.
- •The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care.
- •The patient has an Eastern Cooperative Group (ECOG) performance status of 0-
- •If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
- •The patient has provided written informed consent.
- •The patient is at least 18 years of age at the time of consent
排除标准
- •The patient has clinical or radiological evidence of metastatic disease.
- •The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix.
- •The patient has participated in another investigational drug study within 30 days of scheduled surgery.
- •The patient has an iodine allergy.
- •The patient is pregnant or lactating.
研究组 & 干预措施
Lymphoseek/SPECT-CT/Indocyanine
The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
干预措施: Lymphoseek (Drug)
Lymphoseek/SPECT-CT/Indocyanine
The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
干预措施: Single Photon Emission Computed Tomography (SPECT) (Device)
Lymphoseek/SPECT-CT/Indocyanine
The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
干预措施: Indocyanine Green (ICG) (Drug)
Lymphoseek/SPECT-CT/Indocyanine
The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
干预措施: Neoprobe Gamma Detection System NPB11L(Model1102) (Device)
结局指标
主要结局
Number of Participants With Bilateral SLNs
时间窗: during surgery, an average of 3 hours
A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device.
次要结局
- Overall Detection of SLN Detection(during surgery, an average of 3 hours)
- Number of SLNs Detected by Lymphoseek:(during surgery, an average of 3 hours)
- Location of SLNs Detected by Indocyanine Green(during surgery, an average of 3 hours)
- Location of SLNs Detected by Lymphoseek:(during surgery, an average of 3 hours)
- Number of SLNs Detected by Indocyanine Green(during surgery, an average of 3 hours)
研究者
Amer Karam
Clinical Professor
Stanford University