Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Negative predictive value of the sentinel lymph node technique.
研究概览
简要总结
This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.
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
- •Signed informed consent prior to the performance of any procedure related to the clinical trial.
- •Female, 18 years of age or older at the time of inclusion.
- •Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery.
排除标准
- •Failure to obtain informed consent or revocation of informed consent.
- •Under 18 years of age at the time of inclusion.
- •Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels.
- •Previous pelvic or paraaortic lymphatic surgery.
- •Previous lymphoma.
- •Previous abdomino-pelvic tumor.
- •Previous allergy to Tc99 or ICG.
- •Pregnancy/Breastfeeding.
- •Patients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.
研究组 & 干预措施
Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.
A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes.
干预措施: Sentinel Node Technique (Procedure)
结局指标
主要结局
Negative predictive value of the sentinel lymph node technique.
时间窗: Postoperative (30 days +/- 10 days)
To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard.
次要结局
- Determine Sentinel Lymph Node Procedure Rate(Intraoperative and postoperative (30 days +/- 10 days).)
- Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy(Postoperative (30 days +/- 10 days).)
- Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection(Intraoperative and postoperative (30 days +/- 10 days).)
- Sample Characterization(Baseline visit and Intraoperative)
- Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection(Intraoperative and postoperative (30 days +/- 10 days).)
- Determine the rate of "empty" sentinel lymph node detection.(Postoperative (30 days +/- 10 days).)
- Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate(Intraoperative and postoperative (30 days +/- 10 days).)
- Identify the anatomical location of the sentinel lymph nodes.(Intraoperative and postoperative (30 days +/- 10 days).)
- Determine the number of detected lymph nodes.(Intraoperative and postoperative (30 days +/- 10 days).)
- Rate of overstaging with ultrastaging.(Postoperative (30 days +/- 10 days).)
- Complications related to the sentinel lymph node technique(Intraoperative and postoperative (30 days +/- 10 days).)
- Complications related to lymphadenectomy.(Intraoperative and postoperative (30 days +/- 10 days).)