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NCT Number: NCT04878094

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Indocyanine Green/ICG injection

Diagnostic Test

Intravenous Indocyanine Green/ICG injection will be administered for visualization

PINPOINT endoscopic fluorescence imaging system

Diagnostic Test

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

Diagnostic Test

Standard technique and assessment of anastomosis without the use of NIR angiography

Primary outcomes

Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Chi, MD

CONTACT

[email protected]

212-639-5016

Mario Leitao, MD

CONTACT

[email protected]

212-639-3987

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: May 7, 2021
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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