Clinical trial · Interventional
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study
NCT05071976CI-TRIAL-00096901active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG-NIR angiography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants undergoing a pelvic or abdominal wall reconstruction procedure
- description
- Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center
- interventionNames
- Diagnostic Test: ICG-NIR angiography
Primary outcomes (1)
- measure
- Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
- timeFrame
- Up to 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.