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NCT04878094 · ClinicalTrials.gov registry record · Phase 3
A Study of Intra-operative Imaging in Women With Ovarian Cancer
A Phase 3 study of Ovarian Cancer and Ovarian Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
- 9
- Study locations
NCT04878094: Recruiting Phase 3 study of Ovarian Cancer and Ovarian Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04878094 is a Phase 3 study of Ovarian Cancer and Ovarian Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 310 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (57% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04878094, a Phase 3 study of Ovarian Cancer and Ovarian Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Endoscopy
- DIAGNOSTIC_TEST Intravenous Indocyanine Green/ICG injection
- DIAGNOSTIC_TEST PINPOINT endoscopic fluorescence imaging system
Study Locations (9)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Pennsylvania
- Jefferson Abington Hospital - Willow Grove
Texas
- Houston Methodist Cancer Center (Data Collection Only) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2026-05-03 |
| Phase | Phase 3 |
What NCT04878094 shows while recruiting
NCT04878094 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Endoscopy is the first listed.
NCT04878094 lists 9 locations in 4 states (New York, New Jersey, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04878094 about?
NCT04878094 is a clinical study titled "A Study of Intra-operative Imaging in Women With Ovarian Cancer". 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 imagi...
What is the current status of trial NCT04878094?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2021-05-03. Estimated completion is 2026-05-03.
What conditions does trial NCT04878094 study?
This clinical trial studies the following conditions: Ovarian Cancer, Ovarian Carcinoma.
What interventions are being tested in trial NCT04878094?
The interventions under investigation include: Endoscopy (DIAGNOSTIC_TEST), Intravenous Indocyanine Green/ICG injection (DIAGNOSTIC_TEST), PINPOINT endoscopic fluorescence imaging system (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04878094?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04878094 being conducted?
This trial has 9 study locations across New Jersey, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04878094's enrollment target sits among peer trials
310 70th of 322 higher than 253 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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