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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01673022
First received: August 22, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Endometrial Cancer
Cervical Cancer
Drug: IC Green

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Estimate the sensitivity of the sentinel lymph node [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 640
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673022

Locations
United States, Alabama
USA Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Contact: Jennifer Scalici, MD    251-445-9866      
Contact: Joanie Broemmelsiek, BSN    251-445-9866    jbroemmelsiek@health.southalabama.edu   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Emma Rossi, MD    317-944-7026      
Contact: Melissa Ade    317-944-7026    made@iupui.edu   
United States, Nevada
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Lynn Kowalski, MD    702-739-6467      
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Amanda Jackson, MD    919-843-2077    jbh@med.unc.edu   
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Leigh Cantrell, MD    434-243-0032      
Contact: Tim Howland, BS    434-243-0032    th3vn@virginia.edu   
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Emma Rossi, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01673022     History of Changes
Other Study ID Numbers: 1204008493
Study First Received: August 22, 2012
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 02, 2014