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NCT05071976 Clinical Trial

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

Gynecologic Surgery Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05071976
Other study ID # 21-349
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 24, 2021
Est. completion date September 24, 2024

Study information
Verified date August 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date September 24, 2024
Est. primary completion date September 24, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent and Followup) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk - Commack (Consent and Followup) Commack New York
United States Memorial Sloan Kettering Westchester (Consent and Followup) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent and Followup) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent and Followup) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent and Followup) Rockville Centre New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans 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. Up to 24 months
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