Performance Evaluation of Real-time Fluorescence-guided Resection of Peritoneal Metastases in Ovarian Cancer USing IndoCyanine Green during Interval Cytoreductive Surgery (FOCUS-ICG)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the detection rate of additional peritoneal nodules with near-infrared fluorescence (NIRF) imaging with indocyanine green (ICG) in identifying occult peritoneal metastases during interval cytoreductive surgery in patients with ovarian cancer.
研究概览
简要总结
This study aims to evaluate the performance of ICG-guided near-infrared fluorescence imaging in enhancing intraoperative detection of occult peritoneal metastases during interval cytoreduction surgery in ovarian cancer. Primary objective is to evaluate the detection rate of additional peritoneal nodules with near-infrared fluorescence imaging with indocyanine green in identifying occult peritoneal metastases during interval cytoreductive surgery in patients with ovarian cancer. Female patients aged more than 18 years with histolopathologically confirmed ovarian cancer, FIGO stage III or IV and completed more than or equal to 3 cycles of platinum-based neoadjuvant chemotherapy and scheduled for an interval cytoreductive surgery, ECOG performance status 0 to 2 and provided written informed consent will be included. This study addresses a critical gap by evaluating the real-time utility of ICG NIRF imaging in enhancing intraoperative identification of otherwise occult disease. By focusing on its performance in the post-chemotherapy setting, our work aims to clarify whether this technology can support more complete cytoreduction, guide surgical decision making, and ultimately contribute to improved outcomes for women with advanced ovarian cancer
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 75.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Female patients aged more than 18 years with histolopathologically confirmed ovarian cancer, FIGO stage III or IV and completed more than or equal to three cycles of platinum-based neoadjuvant chemotherapy and scheduled for an interval cytoreductive surgery 2.ECOG performance status 0 to 2 3.Provided written informed consent.
排除标准
- 未提供
结局指标
主要结局
To evaluate the detection rate of additional peritoneal nodules with near-infrared fluorescence (NIRF) imaging with indocyanine green (ICG) in identifying occult peritoneal metastases during interval cytoreductive surgery in patients with ovarian cancer.
时间窗: Detection rate will be calculated based on intraoperative findings and histopathological reports within first 6 months of follow up
次要结局
- 1.To evaluate the Identification rate, histopathological positivity rate of ICG fluorescence-guided biopsies during interval cytoreduction & other diagnostic accuracy parameters like positive predictive value & sensitivity.(2.To determine whether fluorescence guidance during interval cytoreduction alters the extent of surgical resection & identify subset of patients in whom it is ideal.)
研究者
Dr Sampada Vivek Joshi
All India Institute Of Medical Sciences- Jodhpur
