NCT05937620招募中不适用
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
Fundacion Clinic per a la Recerca Biomédica1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
研究概览
简要总结
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial 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
- •Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
- •Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
- •Signing of informed consent by the patient or relative in charge.
- •Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).
排除标准
- •Patients <18 years
- •Pregnancy or breastfeeding
- •Epithelial ovarian tumors stage FIGO III or IV.
- •Impossibility to obtain a biopsy from the tumor.
- •History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
- •Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
- •Patient not able to undergo surgery.
- •Hypersensitivity to active principle, to sodium iodide or iodine allergy.
- •Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
研究组 & 干预措施
Interventional arm
Experimental
All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin
干预措施: 99mTC nanocolloid albumin injection (Diagnostic Test)
Interventional arm
Experimental
All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin
干预措施: ICG injection (Diagnostic Test)
结局指标
主要结局
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
时间窗: Through study completion (an average of 36 months)
Global detection rate of sentinel lymph node in patients having received both tracers.
次要结局
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics(Through study completion (an average of 36 months))
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.(Through study completion (an average of 36 months))
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach(Through study completion (an average of 36 months))
- Evaluation of anatomical distribution of 99mTC draining(Through study completion (an average of 36 months))
- Comparison of lymph node detection with both tracers.(Through study completion (an average of 36 months))
- Evaluation of ultra-staging in micrometastases detection compared to conventional histology.(Through study completion (an average of 36 months))
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.(Through study completion (an average of 36 months))
- Anatomical distribution of sentinel lymph node detected with ICG.(Through study completion (an average of 36 months))
- Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.(Through study completion (an average of 36 months))
- Evaluation of the complications associated with each technique.(Through study completion (an average of 36 months))
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics(Through study completion (an average of 36 months))
- Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.(Through study completion (an average of 36 months))
研究者
研究点 (1)
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