About this trial
This study looks at a new way to use imaging during surgery for women with ovarian cancer. The goal is to see if a special camera system can help reduce problems after surgery, compared to regular methods. The camera uses a glowing dye to check blood flow in real-time, which can help surgeons fix any issues during the operation.
The trial ID is NCT04878094. It is a Phase 3 study, meaning it is looking at how well the treatment works and how safe it is. The trial is not testing a new drug but is using an FDA-regulated device. About 310 participants are expected to join.
Who can join
Women aged 18 and older with ovarian, fallopian tube, or primary peritoneal cancer can join. They should be scheduled for a specific type of surgery. Women who have had allergic reactions to the dye used in the imaging or who need a permanent colostomy cannot participate. The trial team will confirm eligibility for each participant.
Conditions
Ovarian Cancer, Ovarian Carcinoma
The study team makes the final call on eligibility.
What happens in the study
Participants are randomly placed into two groups. One group will have surgery using standard methods, while the other group will have the additional imaging to check blood flow during the procedure. Everyone will receive an injection of a special dye for visualization. The imaging system will be used after the surgery to check the healing area.
Where
This trial is running at 9 locations in the United States. All of them are currently recruiting.
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas
Jefferson Abington Hospital
Willow Grove, Pennsylvania
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York
The first 8 of 9 sites are listed here. The registry record has the full list.