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

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.

Full Title of Study: “Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 24, 2022

Interventions

  • Diagnostic Test: ICG-NIR angiography
    • 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

Arms, Groups and Cohorts

  • Participants undergoing a pelvic or abdominal wall reconstruction procedure
    • Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nadeem Abu-Rustum, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Nadeem Abu-Rustum, MD, 212-639-7051, abu-rusn@MSKCC.ORG

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