Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 101
- 试验地点
- 14
- 主要终点
- False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
研究概览
简要总结
This clinical trial studies positron emission tomography (PET)/computed tomography (CT) and lymph node mapping in finding lymph node metastasis in patients with endometrial cancer that is at high risk of spreading. A PET/CT scan is a procedure that combines the pictures from a PET scan and a CT scan, which are taken at the same time from the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. Lymph node mapping uses a radioactive dye, called indocyanine green solution, to identify lymph nodes that may contain cancer cells. PET/CT and sentinel lymph node mapping may be better ways than surgery to identify cancer in the lymph nodes.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the false negative rate of PET/CT and/or sentinel lymph node mapping in the detection of positive lymph nodes in women with high risk endometrial cancers.
SECONDARY OBJECTIVES:
I. To estimate the sensitivity, specificity, positive predictive value, and negative predictive value of PET/CT and/or sentinel lymph node mapping in the detection of positive lymph nodes in women with high risk endometrial cancer.
II. To determine if a molecular panel of estrogen-induced genes that we have previously identified from retrospective studies correlate with extra-uterine spread including lymph node metastasis at the time of surgical staging for endometrial cancer.
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
- •Histologically confirmed high grade endometrial cancer including grade 3 endometroid, serous, clear cell, malignant mixed Mullerian tumor (MMMT) or any mixed tumor containing one of these cell types
- •Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam
- •Candidate for surgery
- •No evidence of peritoneal disease on preoperative imaging
- •Negative pregnancy test if of child-bearing age
- •No preoperative treatment for endometrial cancer including radiation or chemotherapy
- •Previous hormonal therapy is allowed
排除标准
- •Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
- •Any contraindications to PET/CT or lymph node mapping (inability to control serum glucose to a value of =< 200 mg/dl for fludeoxyglucose F-18 [FDG]-PET/CT)
- •Does not meet histologic criteria
- •Evidence of peritoneal or distant metastasis on preoperative imaging
- •Baseline creatinine (necessary for imaging studies)
研究组 & 干预措施
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Indocyanine Green Solution (Drug)
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Lymph Node Mapping (Procedure)
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Computed Tomography (Procedure)
Diagnostic (PET/CT, lymph node mapping)
Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
干预措施: Lymphadenectomy (Procedure)
结局指标
主要结局
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
时间窗: 36 months
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
时间窗: 36 months
次要结局
- False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure(36 months)
- Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications(36 months)
- False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure(36 months)
- Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications(36 months)