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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NCT04878094

A Study of Intra-operative Imaging in Women With Ovarian Cancer

Active, Not Recruiting
PHASE3All AgesInterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~155 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Intravenous Indocyanine Green/ICG injectionPINPOINT endoscopic fluorescence imaging systemEndoscopy

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
Measured over 45 days post procedure
Ovarian Cancer
Ovarian Carcinoma
9 sites across 4 states
New York4
New Jersey3
Pennsylvania1
Texas1
  • Mario Leitao, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years or older
Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
Scheduled to undergo debulking or cytoreductive surgery
Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
Enrolled and consented before the operation
Completed rectosigmoid resection
Surgeon plans to perform colorectal anastomosis

Exclusion

Documented history of allergic reaction to ICG
Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
Did not undergo rectosigmoid resection intraoperatively
Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
Patient requires permanent colostomy
  • 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.