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A Study of Intra-operative Imaging in Women With Ovarian Cancer
NCT04878094 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
About this study
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
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
Study design
Enrollment target: 310 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2021-05-03
Estimated completion: 2026-05-03
Last updated: 2026-04-09
Interventions
Diagnostic Test: Intravenous Indocyanine Green/ICG injectionDiagnostic Test: PINPOINT endoscopic fluorescence imaging systemDiagnostic Test: Endoscopy
Primary outcomes
- • Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone (45 days post procedure)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactMario Leitao, MD · contact · leitaom@mskcc.org · 212-639-3987
ContactDennis Chi, MD · contact · chid@mskcc.org · 212-639-5016
InvestigatorMario Leitao, MD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (9)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Uniondale, New York, United States
Jefferson Abington HospitalNot Yet Recruiting
Willow Grove, Pennsylvania, United States
Houston Methodist Cancer Center (Data Collection Only)Recruiting
Houston, Texas, United States