Performance Evaluation of Real-time Fluorescence-guided Resection of Peritoneal Metastases in Ovarian Cancer USing IndoCyanine Green during Interval Cytoreductive Surgery (FOCUS-ICG)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AIIMS Jodhpur
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: Detection rate will be calculated based on intraoperative findings and histopathological reports within first 6 months of follow up
Secondary Outcomes
- 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.)
Investigators
Dr Sampada Vivek Joshi
All India Institute Of Medical Sciences- Jodhpur