NCT04878094

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Ovarian Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-03
• Primary completion: 2026-05-03
• Completion: 2026-05-03
• First posted: 2021-05-07
• Last updated: 2026-04-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study