A Study of Intra-operative Imaging in Women With Ovarian Cancer

Phase 3

Recruiting

• Conditions: Ovarian Cancer; Ovarian Carcinoma
• Interventions: Diagnostic Test: Intravenous Indocyanine Green/ICG injection; Diagnostic Test: PINPOINT endoscopic fluorescence imaging system; Diagnostic Test: Endoscopy

• Registration Number: NCT04878094
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-05-03
• Study Completion: 2026-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Endoscopy	Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Arm A	Endoscopy	Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
Arm B	Intravenous Indocyanine Green/ICG injection	Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Arm B	PINPOINT endoscopic fluorescence imaging system	Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography

Primary Outcome Measures

Name	Time	Method
Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone	45 days post procedure	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.

Trial Locations

Locations (8)

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

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