Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Sensitivity
研究概览
简要总结
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
- •Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.
排除标准
- •Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- •Women included in other studies affecting outcome-measures of the present study
研究组 & 干预措施
High risk endometrial cancer
Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy.
干预措施: SLN mapping and removal of PET-positive lymph nodes (Procedure)
Cervical cancer tumor size 2-4 cm
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
干预措施: SLN mapping and removal of PET-positive lymph nodes (Procedure)
结局指标
主要结局
Sensitivity
时间窗: 2 years
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Negative predictive value
时间窗: 2 years
Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes
次要结局
- Positive predictive value(2 years)
- Quality of life rate(3 years)
- Specificity(2 years)
- Incidence of lymphedema(3 years)
- Severity of lymphedema(3 years)
- Prevalence of lymph node metastasis(2 years)
研究者
Sara Sponholtz
MD
University of Southern Denmark