Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging (FIRES)
|ClinicalTrials.gov Identifier: NCT01673022|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : July 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Cervical Cancer||Drug: IC Green||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||490 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: IC Green Arm
One arm only: Receives IC Green for testing of study objective
Drug: IC Green
Other Name: indocyanine green for injection, USP
- Estimate the sensitivity of the sentinel lymph node [ Time Frame: 3 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673022
|United States, Alabama|
|USA Mitchell Cancer Institute|
|Mobile, Alabama, United States, 36604|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Kentucky|
|St. Elizabeth Healthcare|
|Edgewood, Kentucky, United States, 41017|
|United States, Nevada|
|Sunrise Hospital and Medical Center|
|Las Vegas, Nevada, United States, 89109|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Tri Health Good Smaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|United States, Virginia|
|University of Virginia Medical Center|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Emma Rossi, MD||Indiana University|