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RECRUITINGPhase 3INTERVENTIONAL

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

ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Intravenous Indocyanine Green/ICG injection

Intravenous Indocyanine Green/ICG injection will be administered for visualization

DIAGNOSTIC_TEST

PINPOINT endoscopic fluorescence imaging system

After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.

DIAGNOSTIC_TEST

Endoscopy

Standard technique and assessment of anastomosis without the use of NIR angiography

Locations (9)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Jefferson Abington Hospital
Willow Grove, Pennsylvania, United States
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, United States