Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Estimate the sensitivity of the sentinel lymph node
To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. To estimate the false negative predictive value (FNPV) of the sentinel lymph node in determination of lymph node metastases in patients with invasive carcinoma of the cervix and endometrium.
3 years
No
Emma Rossi, MD
Principal Investigator
Indiana University
United States: Food and Drug Administration
1204008493
NCT01673022
May 2012
May 2017
Name | Location |
---|---|
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Indiana University | Indianapolis, Indiana 46202 |