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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2026-10-24

Brief Summary

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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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Detailed Description

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Conditions

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Gynecologic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ICG-NIR angiography

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No