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Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer, Cervical Cancer

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Estimate the sensitivity of the sentinel lymph node

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Emma Rossi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

1204008493

NCT ID:

NCT01673022

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Endometrial Cancer
  • Cervical Cancer
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Adenoma

Name

Location

Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
University of North CarolinaChapel Hill, North Carolina  27599
Indiana UniversityIndianapolis, Indiana  46202