A Study of Intra-operative Imaging in Women With Ovarian Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Carcinoma; Ovarian Cancer

Treatments: Diagnostic Test: Endoscopy; Diagnostic Test: PINPOINT endoscopic fluorescence imaging system; Diagnostic Test: Intravenous Indocyanine Green/ICG injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04878094

21-202

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Randomized to standard technique and assessment of anastomosis without the use of NIR angiography

Treatment:

Diagnostic Test: Endoscopy

Arm B

Experimental group

Description:

Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography

Treatment:

Diagnostic Test: Intravenous Indocyanine Green/ICG injection

Diagnostic Test: PINPOINT endoscopic fluorescence imaging system

Diagnostic Test: Endoscopy