CTRI/2024/08/073145尚未招募2 期
Fluorescence guided surgery using Near-infrared (NIR) imaging for detection of peritoneal metastases in patients undergoing cytoreductive surgery in epithelial ovarian cancer-A feasibility study
AIIMS Delhi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concordance between fluorescent signal-detected peritoneal metastases and histopathology assessment
研究概览
简要总结
Near-infrared fluorescence imaging using indocyanine green can assist in intraoperative detection of ovarian cancer metastases by detection of additional peritoneal metastatic lesions that are not detected either by the naked eye or by palpation and thus help in achieving complete cytoreduction. It would also allow discrimination of malignant from benign residual scar tissue with its fluorescent activity, in patients treated with neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Patients diagnosed with epithelial ovarian cancer with peritoneal metastases undergoing Primary or interval cytoreductive Surgery
- •Age≥ 18yearsold
- •Able to give informed consent.
- •ECOG Performance Score 0-2.
排除标准
- •Exclusion criteria:
- •History of allergy or hypersensitivity against ICG or lodine compounds.
- •Pregnancy and lactation.
- •Prior and current history of Bevacizumab administration.
- •Mucinous Histology.
- •ECOG Performance score 3-4
- •Surgically not meeting resectablity criteria.
结局指标
主要结局
Concordance between fluorescent signal-detected peritoneal metastases and histopathology assessment
时间窗: 4 WEEKS OF SURGERY
次要结局
- Concordance between fluorescent signal-detected lymph nodes and residual and histopathology assessment(24 months)
研究者
RICHA GARG
AIIMS NEW DELHI
研究点 (1)
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