Status:
RECRUITING
A Study of Intra-operative Imaging in Women With Ovarian Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Ovarian Cancer
Ovarian Carcinoma
Eligibility:
FEMALE
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2026
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04878094
Start Date
May 3 2021
End Date
May 3 2026
Last Update
May 30 2025
Active Locations (9)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725