NCT04878094Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 155 (actual)
- First submitted
- 4 May 2021
- Start date
- 3 May 2021
- Primary completion date
- 3 May 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT04878094
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 155
- From 3 May 2021 to the primary completion date, 3 May 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Houston Methodist Cancer Center (Data Collection Only) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
| Jefferson Abington Hospital Coordinator of this site? Confirm its status | Willow Grove | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.