Clinical trial NCT04878094: A Study of Intra-operative Imaging in Women With Ovarian Cancer
Official title: ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Ovarian Carcinoma
Keywords: Ovarian cancer
PINPOINT
rectosigmoid resection
anastomosis
21-202
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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: 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

Primary outcomes:
measure: Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
timeFrame: 45 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
city: Willow Grove
country: United States
facility: Jefferson Abington Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Cancer Center (Data Collection Only)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mario Leitao, MD
role: PRINCIPAL_INVESTIGATOR
References: