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

Ovarian Cancer Clinical Trial

Official title:

ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04878094
• Other study ID #: 21-202
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2021
• Est. completion date: May 3, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Mario Leitao, MD
• Phone: 212-639-3987
• Email: leitaom[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: May 3, 2025
• Est. primary completion date: May 3, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Participant Inclusion Criteria

Part 1 (pre-operative):

• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	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 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 (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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone	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.	45 days post procedure

External Links

•   Memorial Sloan Kettering Cancer Center