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

StatusActive, Not Recruiting
PhasePhase 3
Started2021-05-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 50% 310 → 155 participants
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-08-26
Study Status, Study Design, Contacts/Locations v13
Enrollment closed, study ongoing
Enrollment reduced: 310 → 155 participants
Study sitesdetails revised at 9 of 9 sites
2026-05-19
Study Status, Contacts/Locations v12
Primary completion pushed: 2026-05-03 → 2027-05-03
Completion pushed: 2026-05-03 → 2027-05-03
Study sitesdetails revised at 1 of 9 sites
2026-04-03
Study Status v11
Re-verified, no change to tracked fields
2025-05-29
Study Status, Contacts/Locations v10
Study sites8→9
2025-05-14
Study Status v9
Primary completion date2025-05-03→2026-05-03
Completion date2025-05-03→2026-05-03
Show 8 earlier versions
2024-10-30
Study Status, Eligibility v8
Eligibility criteria+18 characters
Participant Inclusion Criteria Part 1 (pre-operative): 18 years or older Diagnosed with primary or recurrent ovarian, fallopian tube, [...]
2024-04-11
Study Status v7
Re-verified, no change to tracked fields
2023-08-08
Study Status, Contacts/Locations v6
Study sitescontacts updated at 7 of 8 sites
2023-06-29
Study Status, Contacts/Locations v5
Study sites8 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities) MemoralMemorial Sloan Kettering Monmouth (Limited Protocol Activities) MemoralMemorial Sloan Kettering Westchester (Limited Protocol Activities)
2023-04-26
Study Status, Contacts/Locations v4
Study sites7→8
2023-03-09
Study Status, Study Design v3
Enrollment target538→310
2022-06-21
2 amendments v1-v2
2 re-verifications since 2022-05-04, no change to tracked fields
2021-05-04
Original filing
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.
Trial Details
NCT Number NCT04878094
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Ovarian Cancer, Ovarian Carcinoma
Enrollment 155 participants
Start Date 2021-05-03
Primary Completion 2027-05-03 (estimated)
Study Completion 2027-05-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-27