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Procedure

Intra-operative Imaging for Ovarian Cancer

Phase 3
Recruiting
Led By Oliver Zivanovic, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed rectosigmoid resection
Scheduled to undergo debulking or cytoreductive surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days post procedure
Awards & highlights

Study Summary

This trial will test whether using the PINPOINT imaging system to assess blood flow during surgery can reduce the risk of complications after ovarian cancer surgery.

Who is the study for?
This trial is for women with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for surgery to remove the tumor. They must be enrolled before surgery and have a part of their bowel removed that's close to the rectum. Women can't join if they're allergic to ICG dye or need a permanent colostomy.Check my eligibility
What is being tested?
The study tests if using the PINPOINT system during surgery helps prevent leaks and complications by showing blood flow in the bowel with a special camera and glowing dye. This could allow surgeons to fix issues on-the-spot compared to standard methods.See study design
What are the potential side effects?
Potential side effects may include an allergic reaction to the Indocyanine Green (ICG) dye used for imaging, which is rare but can cause symptoms like rash, swelling, or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had surgery to remove part of my lower colon or rectum.
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I am scheduled for surgery to remove as much of my cancer as possible.
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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.
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My surgeon plans to connect two parts of my colon.
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I might need surgery in my lower colon during a tumor removal operation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment3 Interventions
Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Group II: Arm AActive Control1 Intervention
Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopy
2019
Completed Phase 3
~3320

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,942 Previous Clinical Trials
588,716 Total Patients Enrolled
73 Trials studying Ovarian Cancer
42,715 Patients Enrolled for Ovarian Cancer
Oliver Zivanovic, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
338 Total Patients Enrolled
2 Trials studying Ovarian Cancer
108 Patients Enrolled for Ovarian Cancer
Mario Leitao, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
2,256 Total Patients Enrolled

Media Library

PINPOINT endoscopic fluorescence imaging system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04878094 — Phase 3
Ovarian Cancer Research Study Groups: Arm B, Arm A
Ovarian Cancer Clinical Trial 2023: PINPOINT endoscopic fluorescence imaging system Highlights & Side Effects. Trial Name: NCT04878094 — Phase 3
PINPOINT endoscopic fluorescence imaging system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878094 — Phase 3
~65 spots leftby May 2025
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