Dysautonomia International

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

Purpose

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.

Conditions

Ovarian Cancer
Ovarian Carcinoma

Eligibility

Eligible Ages: All ages
Eligible Sex: Female
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Arm A	Randomized to standard technique and assessment of anastomosis without the use of NIR angiography	Diagnostic Test: Endoscopy Standard technique and assessment of anastomosis without the use of NIR angiography
Experimental Arm B	Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography	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

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920