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NCT04878094 | RECRUITING | Ovarian Cancer

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

Condition or disease

Ovarian Cancer

Ovarian Carcinoma

Intervention/treatment

Intravenous Indocyanine Green/ICG injection

PINPOINT endoscopic fluorescence imaging system

Endoscopy

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 310 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
Actual Study Start Date : 2021-05-03
Estimated Primary Completion Date : 2025-05-03
Estimated Study Completion Date : 2025-05-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
    • A Study of Intra-operative Imaging in Women With Ovarian Cancer

    Location Details

    NCT04878094

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, New Jersey

    Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, United States, 07920

    RECRUITING

    United States, New Jersey

    Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, United States, 07748

    RECRUITING

    United States, New Jersey

    Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, United States, 07645

    RECRUITING

    United States, New York

    Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, United States, 11725

    RECRUITING

    United States, New York

    Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, United States, 10604

    RECRUITING

    United States, New York

    Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, United States, 10065

    RECRUITING

    United States, New York

    Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, United States, 11553

    NOT YET RECRUITING

    United States, Pennsylvania

    Jefferson Abington Hospital

    Willow Grove, Pennsylvania, United States, 19090