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

May 19, 2026 updated by: Memorial Sloan Kettering Cancer Center

ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dennis Chi, MD
  • Phone Number: 212-639-5016
  • Email: chid@mskcc.org

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Mario Leitao, MD
          • Phone Number: 212-639-3987
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Jefferson Abington Hospital
        • Contact:
          • Leah Moukarzel, MD
          • Phone Number: 215-481-4000
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Cancer Center (Data Collection Only)
        • Contact:
          • Tarrik Zaid, MD
          • Phone Number: 281-275-0880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
Diagnostic test: Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Experimental: Arm B
Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Diagnostic test: Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mario Leitao, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Estimated)

May 3, 2027

Study Completion (Estimated)

May 3, 2027

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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