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
1 other identifier
interventional
310
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 ovarian-cancer
Started May 2021
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2026
CompletedApril 9, 2026
April 1, 2026
5 years
May 4, 2021
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm A
ACTIVE COMPARATORRandomized to standard technique and assessment of anastomosis without the use of NIR angiography
Arm B
EXPERIMENTALRandomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Interventions
Intravenous Indocyanine Green/ICG injection will be administered for visualization
Standard technique and assessment of anastomosis without the use of NIR angiography
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.
Eligibility Criteria
You may qualify if:
- Part 1 (pre-operative):
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Jefferson Abington Hospital
Willow Grove, Pennsylvania, 19090, United States
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, 77030, United States
Related Publications (1)
Leitao MM Jr, Iasonos A, Tomberlin M, Moukarzel LA, Price H, Bennetti G, Ramesh B, Chi DS, Long Roche K, Sonoda Y, Al-Niami A, Mueller JJ, Gardner GJ, Broach V, Jewell EL, Kim S, Feinberg J, Abu-Rustum NR, Zivanovic O. ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer. Int J Gynecol Cancer. 2024 Jul 1;34(7):1098-1101. doi: 10.1136/ijgc-2024-005395.
PMID: 38514101DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Leitao, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
May 3, 2021
Primary Completion
May 3, 2026
Study Completion
May 3, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.