Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopy | Diagnostic Test | — | UNRESOLVED |
| Intravenous Indocyanine Green/ICG injection | Diagnostic Test | — | UNRESOLVED |
| PINPOINT endoscopic fluorescence imaging system | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
- interventionNames
- Diagnostic Test: Endoscopy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
- interventionNames
- Diagnostic Test: Intravenous Indocyanine Green/ICG injection
- Diagnostic Test: PINPOINT endoscopic fluorescence imaging system
- Diagnostic Test: Endoscopy
Primary outcomes (1)
- measure
- Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLeitao 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 38514101