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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05071976

Enrollment

Registered

2021-10-08

Start date

2021-09-24

Completion date

2026-10-24

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Surgery

Keywords

gynecologic surgery, abdominal wall reconstruction procedure, pelvic reconstruction procedure, Near-Infrared Fluorescence Imaging, ICG, 21-349, 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.

Interventions

DIAGNOSTIC_TESTICG-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026