Clinical trial NCT01673022
Conditions: Endometrial Cancer Cervical Cancer
Sponsor: Indiana University
Start date: 2012-05-01; Completion date: 2017-01-01
Enrollment: 430 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
Brief Summary:

Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after they are asleep from anesthesia prior to performing the surgery. During the surgery, the surgeon will activate the robotic camera that is being used to visualize the internal organs changing it to a special mode of imaging called near infrared imaging. The near infrared imaging will allow the surgeon to see where the dye that was injected into the cervix has spread. The dye travels through vessels called lymphatic channels to nodules called "sentinel lymph nodes". These are the tissues the surgeon is most interested in removing in order to see if there has been spread of their cancer to those nodules. The dye that travels to the lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are indistinguishable from the surrounding fatty tissue.

The nodes that have dye in them will be removed from the patient and sent to the pathologist, where they will be very closely examined, called ultrasectioning, for cancer spread. The surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue that surrounded the sentinel lymph node that did not stain with the dye), as these are the "non-sentinel lymph nodes", and are the tissue that is traditionally removed with endometrial and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will also be examined for evidence of cancer spread. The researchers will compare the pathology results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in the non-sentinel nodes.

Arms: arm 1: One arm only: Receives IC Green for testing of study objective
Interventions: intervention 1: IC Green
Intervention descriptions: intervention 1: IC Green

Protocol documents: