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

Recruiting
years of age
Female
Phase 3

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Overview

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):

  • 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

Study details

Ovarian Cancer, Ovarian Carcinoma

NCT04878094

Memorial Sloan Kettering Cancer Center

26 January 2024

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