ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer.
Mario M Leitao, Alexia Iasonos, Morgan Tomberlin...
https://pubmed.ncbi.nlm.nih.gov/38514101Actively Recruiting
Phase 3
FEMALE
ID04878094
ARIA II: A Phase III Randomized Trial of Near-Infrared Angiography During Rectosigmoid Surgery in Women With Ovarian Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-20
310
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether using the PINPOINT imaging system during surgery can lower the risk of complications like anastomotic leaks after bowel surgery in women with ovarian cancer. This system uses a special camera and glowing dye to check blood flow in the bowel in real time. The study compares this new imaging method with the usual surgical assessments to see if it improves outcomes. Participants will be randomly assigned to one of two groups: one group will receive the standard surgical technique without the imaging system, and the other will have the additional PINPOINT imaging to assess blood flow before and after the bowel connection is made. The imaging involves an intravenous injection of a fluorescent dye and the use of the PINPOINT camera to guide the surgeon during the operation. During the study, participants will be monitored for complications within 30 days after surgery, focusing on the occurrence of leaks at the bowel connection site. The main outcome is the reduction in risk of these leaks. The study involves assessments before, during, and after surgery, with follow-up up to 45 days after the procedure. The trial is conducted without masking, and it is sponsored by Memorial Sloan Kettering Cancer Center.
CONDITIONS
Brief Title
A Study of Intra-operative Imaging in Women With Ovarian Cancer
Who Can Participate
FEMALE
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
- Scheduled for debulking or cytoreductive surgery
- Suspected need for low anterior rectosigmoid resection during surgery
- Enrolled and consented before the operation
- Completed rectosigmoid resection intraoperatively
- Surgeon plans to perform colorectal anastomosis
You will not qualify if you...
- Documented allergic reaction to Indocyanine Green (ICG)
- Not approached for study enrollment before unexpected low anterior rectosigmoid resection
- Did not undergo rectosigmoid resection during surgery
- Rectosigmoid resection for other gynecologic cancers
- Patient requires permanent colostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Surgery day
During surgery, participants undergo imaging assessments including intravenous Indocyanine Green injection and the use of the PINPOINT endoscopic fluorescence imaging system or standard endoscopy to evaluate anastomotic perfusion.
1 intraoperative visit
Long-term Monitoring
Duration - 45 days post surgery
Participants are monitored for 45 days after surgery to assess for postoperative outcomes such as anastomotic leaks.
Follow-up visits as scheduled up to 45 days
Trial Site Locations
Total: 9 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
8
Jefferson Abington Hospital
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
9
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
M
Mario Leitao, MD
D
Dennis Chi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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