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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing a pelvic or abdominal wall reconstruction procedure | Experimental | Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadeem Abu-Rustum, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and Followup) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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|
| Memorial Sloan Kettering Monmouth (Consent and Followup) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Consent and Followup) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk - Commack (Consent and Followup) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent and Followup) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent and Followup) | Rockville Centre | New York | 11553 | United States |