A Study of Intra-operative Imaging in Women With Ovarian Cancer
NCT ID: NCT04878094
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
310 participants
INTERVENTIONAL
2021-05-03
2026-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm A
Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Arm B
Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Intravenous Indocyanine Green/ICG injection
Intravenous Indocyanine Green/ICG injection will be administered for visualization
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.
Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Interventions
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Intravenous Indocyanine Green/ICG injection
Intravenous Indocyanine Green/ICG injection will be administered for visualization
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.
Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mario Leitao, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Jefferson Abington Hospital
Willow Grove, Pennsylvania, United States
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Leah Moukarzel, MD
Role: primary
Tarrik Zaid, MD
Role: primary
References
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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.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-202
Identifier Type: -
Identifier Source: org_study_id
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