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

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

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