Active — Not RecruitingNot Applicable

A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery

United States15 participantsStarted 2021-09-24

Plain-language summary

The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK. * Age ≥18 years. Exclusion Criteria: * Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal). * Women with a history of cirrhosis or other chronic liver disease. * Women with a documented severe or life threatening allergy to iodine. * Women with an allergy to ICG or severe allergy to iodinated contrast. * Women undergoing any free flap (non-pedicled) reconstruction.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans

Timeframe: Up to 24 months

Trial details

NCT IDNCT05071976

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-24

View on ClinicalTrials.gov More Gynecologic Surgery trials