Completed

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

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What is being tested

IC Green

Drug
Who is being recruted

Urogenital Diseases+11

+ Genital Diseases

+ Uterine Cervical Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorIndiana University
Last updated: July 24, 2018
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Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorIndiana University
Last updated: July 24, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

430 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesUterine Cervical NeoplasmsEndometrial Neoplasms

Criteria

6 inclusion criteria required to participate
Patients must be able to sign an informed consent in English language

Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype)

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 meet criteria for robotic surgical approach

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6 exclusion criteria prevent from participating
Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging

Patients who are pregnant

Patients who have had previous retroperitoneal surgery

Patients who have iodide allergies

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

USA Mitchell Cancer Institute

Mobile, United StatesOpen USA Mitchell Cancer Institute in Google Maps

Indiana University

Indianapolis, United States

St. Elizabeth Healthcare

Edgewood, United States

Sunrise Hospital and Medical Center

Las Vegas, United States
Completed7 Study Centers