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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Gynecologic Surgery

Treatments: Diagnostic Test: ICG-NIR angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05071976

21-349

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Participants undergoing a pelvic or abdominal wall reconstruction procedure

Experimental group

Description:

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

Treatment:

Diagnostic Test: ICG-NIR angiography