Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging

Completed · Not applicable

Conditions studied: Endometrial Cancer, Cervical Cancer

In brief

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.

Key facts

Study ID

NCT01673022

Run by

Indiana University

People needed

430

Starts

2012-05-01

Expected to finish

2017-01-01

Last updated by the study team

2018-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype).
• Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy
• Patients must meet criteria for robotic surgical approach:
• Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma.
• Patients must be able to sign an informed consent in English language.
• Patients with known liver disease will require normal range liver function tests as determined by pre-operative labs drawn within 30 days of surgery.

You may not qualify if…

• Patients who have iodide allergies
• Patients who have had previous retroperitoneal surgery
• Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging.
• Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation).
• Patients who are pregnant.
• Patients with documented liver disease who have abnormalities of liver function tests.

Where it is running

• USA Mitchell Cancer Institute — Mobile, Alabama, United States
• Indiana University — Indianapolis, Indiana, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• Sunrise Hospital and Medical Center — Las Vegas, Nevada, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Tri Health Good Smaritan Hospital — Cincinnati, Ohio, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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