NCT05071976

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2021Oct 2026

Study Start

First participant enrolled

September 24, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2026

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

5.1 years

First QC Date

September 28, 2021

Last Update Submit

October 30, 2025

Conditions

Gynecologic Surgery

Keywords

gynecologic surgeryabdominal wall reconstruction procedurepelvic reconstruction procedureNear-Infrared Fluorescence ImagingICG21-349Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Diagnostic Test: ICG-NIR angiography

Interventions

ICG-NIR angiographyDIAGNOSTIC_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

Participants undergoing a pelvic or abdominal wall reconstruction procedure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
  • Age ≥18 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent and Followup)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Followup)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Followup)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Consent and Followup)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent and Followup)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Followup)

Rockville Centre, New York, 11553, United States

Location

Related Links

Study Officials

  • Nadeem Abu-Rustum, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 8, 2021

Study Start

September 24, 2021

Primary Completion (Estimated)

October 24, 2026

Study Completion (Estimated)

October 24, 2026

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)