Sentinel Node in Ovarian Cancer: SONAR-2
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.
研究概览
简要总结
Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered, especially if a SN procedure still is feasable in patients with OC through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected, either during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result) or at a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).
详细描述
Rationale:
As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph node or sentinel node (SN). If the SN does not contain cancer, then there is a high likelihood that the cancer has not spread to other lymph nodes. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity. The SN technique has been proven to be effective in other cancers such as breast cancer and malignant melanoma. In the gynaecological field it has been shown to be effective in vulvar cancer. Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered.
Objectives:
-
To determine whether or not a SN procedure in patients with OC is feasible through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected
-
during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result)
-
during a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy), which becomes actual when a previously resected apparently benign ovarian tumour appears to be malignant at definite pathology.
-
To determine if blue colorization of the sentinel nodes after injection of blue dye is related to the time-interval between injection and retroperitoneal exploration?
-
To determine if the technique becomes more accurate by using a mobile gamma-camera guidance during the surgical procedure.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy. Only when a malignancy is confirmed by frozen section, the SNs will be removed prior to proceeding with a complete staging procedure.
- •Patients in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.
- •Mentally competent to give informed consent.
排除标准
- •Previous vascular surgery of the aorta, caval vein, and/or iliac vessels.
- •Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region.
- •History of a malignant lymphoma.
- •History of a malignant tumour in the abdominal cavity.
- •Previous allergic reaction to blue dye.
- •Pregnant or lactating patients.
- •An allergy for human albumin.
结局指标
主要结局
Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.
时间窗: During the surgical procedure
次要结局
- Number of blue colorized sentinel nodes (%) 15, 30, 45, and 60 minutes after injection.(During the surgical procedure)