A Study of Intra-operative Imaging in Women With Ovarian Cancer
This study is investigating whether using a special imaging system called PINPOINT during surgery for ovarian cancer can help reduce complications, specifically anastomotic leaks (where surgical connections don't heal properly). The PINPOINT system uses a fluorescent (glowing) dye called Intravenous Indocyanine Green/ICG and a special camera to show blood flow in real-time. This allows surgeons to identify and fix any issues during the operation. The study aims to see if this method is better than standard surgical assessment alone. You may be able to join if you are a woman aged 18 or older with ovarian, fallopian tube, or primary peritoneal cancer, are scheduled for debulking surgery, and are expected to need a rectosigmoid resection. The study is currently unclear on its recruitment status and plans to enroll 310 participants. Success will be measured by a reduction in the risk of anastomotic leaks 30 days after surgery.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 310 women.
- What's involved
- You would undergo an Intravenous Indocyanine Green/ICG injection and the PINPOINT endoscopic fluorescence imaging system would be used during your surgery. Standard endoscopy would also be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured 45 days after the procedure to assess the risk of anastomotic leak.
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A Study of Intra-operative Imaging in Women With Ovarian Cancer
At a glance
Conditions
Where it's being run
9 sites across 4 statesStudy leadership
- Mario Leitao, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone45 days post procedure
To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone.