A Study of Intra-operative Imaging in Women With Ovarian Cancer
Recruiting
Phase 3
Interventional Study
Ovarian Cancer
Ovarian Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 310 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Other
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About This Trial
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 …
Trial Locations
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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…
Contacts