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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gynecologic Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICG-NIR angiography

Diagnostic 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

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Oct 8, 2021
Registry last updated: Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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