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

Not Applicable

Active, not recruiting

• Conditions: Gynecologic Surgery
• Interventions: Diagnostic Test: ICG-NIR angiography

• 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

Study Timeline

• Study Start: 2021-09-24
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-09-24
• Study Completion: 2025-09-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants undergoing a pelvic or abdominal wall reconstruction procedure	ICG-NIR angiography	Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center

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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent and Followup); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent and Followup); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Followup); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Consent and Followup); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Consent and Followup); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent and Followup); 🇺🇸 Rockville Centre, New York, United States