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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer, Ovarian Carcinoma

Intervention / Treatment
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* Diagnostic Test: Intravenous Indocyanine Green/ICG injection
* Diagnostic Test: PINPOINT endoscopic fluorescence imaging system
* Diagnostic Test: Endoscopy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Randomized to standard technique and assessment of anastomosis without the use of NIR angiography | Diagnostic Test: Endoscopy<br>* Standard technique and assessment of anastomosis without the use of NIR angiography<br>|
| Experimental: Arm B<br>Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography | Diagnostic Test: Intravenous Indocyanine Green/ICG injection<br>* Intravenous Indocyanine Green/ICG injection will be administered for visualization<br>Diagnostic Test: PINPOINT endoscopic fluorescence imaging system<br>* 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.<br>Diagnostic Test: Endoscopy<br>* Standard technique and assessment of anastomosis without the use of NIR angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone | To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone. | 45 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, PINPOINT, rectosigmoid resection, anastomosis, 21-202, Memorial Sloan Kettering Cancer Center