A Study of Intra-operative Imaging in Women With Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorMemorial Sloan Kettering Cancer Center
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 the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Documented history of allergic reaction to ICG
Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
Did not undergo rectosigmoid resection intraoperatively
Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous Indocyanine Green/ICG injection
Diagnostic testIntravenous Indocyanine Green/ICG injection will be administered for visualization
PINPOINT endoscopic fluorescence imaging system
Diagnostic testAfter resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.
Endoscopy
Diagnostic testStandard technique and assessment of anastomosis without the use of NIR angiography
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Arm AActive comparator 1 intervention
Group B: Arm BExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
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.
Time frame
45 days post procedureSponsors and contacts
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Source ClinicalTrials.gov