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NCT04878094PHASE3Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

5/3/2021

Completion Date

5/3/2027

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 Criteria

Age Range: No minimum to No maximum

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

Interventions

DIAGNOSTIC_TEST

Intravenous Indocyanine Green/ICG injection

DIAGNOSTIC_TEST

PINPOINT endoscopic fluorescence imaging system

DIAGNOSTIC_TEST

Endoscopy

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Conditions

Ovarian CancerOvarian Carcinoma

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York 11553

United States

Jefferson Abington Hospital

Willow Grove, Pennsylvania 19090

United States

Houston Methodist Cancer Center (Data Collection Only)

Houston, Texas 77030

United States