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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04878094
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous Indocyanine Green/ICG injection — DIAGNOSTIC_TEST
    Intravenous Indocyanine Green/ICG injection will be administered for visualization
  • PINPOINT endoscopic fluorescence imaging system — DIAGNOSTIC_TEST
    After 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_TEST
    Standard technique and assessment of anastomosis without the use of NIR angiography

Study Details

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.

Key Dates

Start date
May 3, 2021
Status verified
May 2026
Primary completion
May 3, 2027
Completion
May 3, 2027

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Arm A
    Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
  • Experimental: Arm B
    Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography

Primary Outcome Measure

Reduction of 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 procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Mario Leitao, MD
212-639-3987
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Mario Leitao, MD
212-639-3987
Jefferson Abington HospitalWillow GrovePennsylvania19090
Leah Moukarzel, MD
215-481-4000
Houston Methodist Cancer Center (Data Collection Only)HoustonTexas77030
Tarrik Zaid, MD
281-275-0880

Find similar trials in Basking Ridge, NJ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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