NCT04878094 A Study of Intra-operative Imaging in Women With Ovarian Cancer
| NCT ID | NCT04878094 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2021-05-03 |
| Primary Completion | 2027-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 310 participants in total. It began in 2021-05-03 with a primary completion date of 2027-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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 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
Contact & Investigator
Mario Leitao, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04878094 clinical trial?
This trial is open to female participants only, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04878094 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 310 participants.
Is NCT04878094 currently recruiting?
Yes, NCT04878094 is actively recruiting participants. Contact the research team at leitaom@mskcc.org for enrollment information.
Where is the NCT04878094 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 5 additional locations.
Who is sponsoring the NCT04878094 clinical trial?
NCT04878094 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Mario Leitao, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 310 participants.
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