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

Summary

The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.

Eligibility

Participant Inclusion Criteria

Part 1 (pre-operative):

* 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

Part 2 (intra-operative):

* Completed rectosigmoid resection
* Surgeon plans to perform colorectal anastomosis

Participant Exclusion Criteria

Part 1 (pre-operative):

* Documented history of allergic reaction to ICG
* Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection

Part 2 (intra-operative):

* Did not undergo rectosigmoid resection intraoperatively
* Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
* Patient requires permanent colostomy

Conditions3

Locations9 sites

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