Brief Title
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging
Official Title
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
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.
Study Type
Interventional
Primary Outcome
Estimate the Sensitivity of the Sentinel Lymph Node
Condition
Endometrial Cancer
Intervention
IC Green
Study Arms / Comparison Groups
IC Green Arm
Description: One arm only: Receives IC Green for testing of study objective
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
430
Start Date
May 2012
Completion Date
January 2017
Primary Completion Date
January 2017
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Emma Rossi, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01673022
Organization ID
1204008493
Responsible Party
Sponsor
Study Sponsor
Indiana University
Study Sponsor
Emma Rossi, MD, Principal Investigator, Indiana University
Verification Date
July 2017