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
Active Not Recruiting

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

First listed
May 7, 2021
Start date
May 3, 2021
Status verified
Aug 2026
Primary completion
May 3, 2027
Completion
May 3, 2027

Study Design

Enrollment
155 participants (actual)
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 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553-
Jefferson Abington HospitalWillow GrovePennsylvania19090-
Houston Methodist Cancer Center (Data Collection Only)HoustonTexas77030-

Find similar trials in Basking Ridge, NJ

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials
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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