A Study of Intra-operative Imaging in Women With Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Indocyanine Green/ICG injection, PINPOINT endoscopic fluorescence imaging system, Endoscopy.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Ovarian Carcinoma. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
Overview
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.
Interventions
- Diagnostic test Intravenous Indocyanine Green/ICG injection
Intravenous Indocyanine Green/ICG injection will be administered for visualization - Diagnostic test PINPOINT endoscopic fluorescence imaging system
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. - Diagnostic test Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Primary outcome measures
- Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone [Time frame: 45 days post 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 9 centers
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale
- Jefferson Abington Hospital — Willow Grove
- … and 1 more center
Publications
- 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 PMID 38514101
Identifiers
NCT: NCT04878094 · 21-202