A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
- Conditions
- Gynecologic Surgery
- Registration Number
- NCT05071976
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 15
- Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
- Age ≥18 years.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans Up to 24 months The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Followup)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and Followup)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Consent and Followup)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent and Followup)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Consent and Followup)
🇺🇸Rockville Centre, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent and Followup)🇺🇸Basking Ridge, New Jersey, United States