Using advanced imaging during surgery for ovarian cancer
ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
This study is testing if a special imaging system can help surgeons during ovarian cancer surgery to spot and fix problems with blood flow in the bowel, potentially reducing complications for women undergoing the procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 9 sites (Basking Ridge, New Jersey and 8 other locations) |
| Trial ID | NCT04878094 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the PINPOINT imaging system during surgery for women with ovarian cancer. It aims to determine if this technology can reduce complications, such as anastomotic leaks, by providing real-time evaluation of blood flow in the bowel. Participants will receive an intravenous injection of a fluorescent dye, allowing surgeons to identify and address potential issues during the procedure. The study focuses on women scheduled for debulking or cytoreductive surgery who may require rectosigmoid resection.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer scheduled for specific surgical procedures.
Not a fit: Patients who have a documented allergy to the imaging dye or those requiring a permanent colostomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer surgical complications and improved outcomes for patients undergoing surgery for ovarian cancer.
How similar studies have performed: Other studies using intra-operative imaging technologies have shown promise in reducing surgical complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 8 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
- Jefferson Abington Hospital — Willow Grove, Pennsylvania, United States (Not_yet_recruiting)
- Houston Methodist Cancer Center (Data Collection Only) — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mario Leitao, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Mario Leitao, MD
- Email: leitaom@mskcc.org
- Phone: 212-639-3987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.