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

RecruitingPhase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Ovarian Cancer, Ovarian Carcinoma

Interventions: Intravenous Indocyanine Green/ICG injection, PINPOINT endoscopic fluorescence imaging system, Endoscopy

Countries: United States

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 overview

Sex: FEMALE

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (9)

Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Uniondale, New York, United States
Willow Grove, Pennsylvania, United States
Houston, Texas, United States