RecruitingPhase 3NCT04878094

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

310 participants

Start Date

May 3, 2021

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Ovarian Carcinoma

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study tests intraoperative (during surgery) fluorescence imaging using a dye called ICG (indocyanine green) to help surgeons check whether a bowel reconnection (anastomosis) after rectal resection during ovarian cancer surgery has a good blood supply, potentially reducing the risk of a dangerous leak. **You may be eligible if...** - You are 18 or older with ovarian, fallopian tube, or primary peritoneal cancer - You are scheduled for debulking or tumor-reducing surgery - It is expected that part of your rectum or sigmoid colon will need to be removed and reconnected during the surgery - You are enrolled and consented before the operation **You may NOT be eligible if...** - You have a documented allergy to ICG dye - You were not approached for enrollment before an unexpected rectal surgery occurred - Your rectal surgery was for a different type of gynecologic cancer - You require a permanent colostomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTIntravenous Indocyanine Green/ICG injection

Intravenous Indocyanine Green/ICG injection will be administered for visualization

DIAGNOSTIC_TESTPINPOINT 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.

DIAGNOSTIC_TESTEndoscopy

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