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Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluorescence-guided sentinel lymph node detection
Sponsored by
Swedish Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proven endometrial carcinoma
  • Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
  • Must be 18 years of age and older
  • Must be able to comply with all the study procedures

Exclusion Criteria:

  • Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal
  • Uremia, serum creatinine > 2.0 mg/dl
  • Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
  • Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
  • Pregnant
  • Currently participating in a drug, biologic and/or device treatment study
  • Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures

Sites / Locations

  • Swedish Medical Center Issaquah Campus
  • Pacific Gynecology Specialists
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG Dye

Arm Description

Fluorescence-guided sentinel lymph node detection

Outcomes

Primary Outcome Measures

Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.

Secondary Outcome Measures

Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
In cancer, "upstaging" is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred.

Full Information

First Posted
March 21, 2012
Last Updated
November 16, 2016
Sponsor
Swedish Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01562106
Brief Title
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
Official Title
A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.
Detailed Description
In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG Dye
Arm Type
Experimental
Arm Description
Fluorescence-guided sentinel lymph node detection
Intervention Type
Procedure
Intervention Name(s)
Fluorescence-guided sentinel lymph node detection
Intervention Description
During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.
Primary Outcome Measure Information:
Title
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Time Frame
Average expected time of 12 weeks
Secondary Outcome Measure Information:
Title
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
Description
In cancer, "upstaging" is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred.
Time Frame
Average expected time of 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proven endometrial carcinoma Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care Must be 18 years of age and older Must be able to comply with all the study procedures Exclusion Criteria: Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal Uremia, serum creatinine > 2.0 mg/dl Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage Pregnant Currently participating in a drug, biologic and/or device treatment study Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Paley, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center Issaquah Campus
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

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