Ovarian Cancer Clinical Trial

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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.

View Eligibility Criteria

Eligibility Criteria

Participant Inclusion Criteria

Part 1 (pre-operative):

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

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There are 7 Locations for this study

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Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge New Jersey, 07920, United States More Info