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

Memorial Sloan Kettering Cancer Center7 sites in 1 country15 target enrollmentSeptember 24, 2021

ConditionsGynecologic Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gynecologic Surgery
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 15
Locations: 7
Primary Endpoint: Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 24, 2021

End Date

October 24, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.