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临床试验/CTRI/2025/10/095889
CTRI/2025/10/095889尚未招募不适用

Performance Evaluation of Real-time Fluorescence-guided Resection of Peritoneal Metastases in Ovarian Cancer USing IndoCyanine Green during Interval Cytoreductive Surgery (FOCUS-ICG)

AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS Jodhpur
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

发起方
AIIMS Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sampada Vivek Joshi

All India Institute Of Medical Sciences- Jodhpur

研究点 (1)

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