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

N/AActive Not RecruitingNCT05071976

Memorial Sloan Kettering Cancer Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gynecologic Surgery

Interventions

ICG-NIR angiographyDIAGNOSTIC_TEST

Capture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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