Finished
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging
NCT01673022 · Indiana University · Updated 24 July 2018
- What is being tested
- IC Green
- For
- Endometrial Cancer; Cervical Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 430 people. The full rules are on the registry page.
- Where
- United States (7 sites)
- When
- Starts or started May 2012, ends Jan 2017. Registered 27 Aug 2012.
- Results
- Posted on the registry on 24 July 2018.
In the researchers' words
Description: This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging. Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.
Sites
- USA Mitchell Cancer InstituteMobile, Alabama, United States
- Indiana UniversityIndianapolis, Indiana, United States
- St. Elizabeth HealthcareEdgewood, Kentucky, United States
- Sunrise Hospital and Medical CenterLas Vegas, Nevada, United States
- University of North CarolinaChapel Hill, North Carolina, United States
- Tri Health Good Smaritan HospitalCincinnati, Ohio, United States
- University of Virginia Medical CenterCharlottesville, Virginia, United States
