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

NCT ID: NCT01673022

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Endometrial Cancer; Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IC Green Arm

One arm only: Receives IC Green for testing of study objective

Group Type: EXPERIMENTAL

IC Green

Intervention Type: DRUG

IC Green

Interventions

IC Green

IC Green

Intervention Type: DRUG

Other Intervention Names

indocyanine green for injection, USP

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

USA Mitchell Cancer Institute

Mobile, Alabama, United States

Indiana University

Indianapolis, Indiana, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Tri Health Good Smaritan Hospital

Cincinnati, Ohio, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Countries

United States

References

Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.

Reference Type: DERIVED

PMID: 28159465 (View on PubMed)

Other Identifiers

1204008493

Identifier Type: -

Identifier Source: org_study_id