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
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.
Study Type
Interventional
Primary Outcome
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Secondary Outcome
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
Condition
Endometrial Cancer
Intervention
Fluorescence-guided sentinel lymph node detection
Study Arms / Comparison Groups
ICG Dye
Description: Fluorescence-guided sentinel lymph node detection
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
123
Start Date
February 2012
Completion Date
August 2016
Primary Completion Date
September 2015
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pamela Paley, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01562106
Organization ID
IR 5197
Responsible Party
Sponsor
Study Sponsor
Swedish Medical Center
Study Sponsor
Pamela Paley, MD, Principal Investigator, Swedish Medical Center
Verification Date
November 2016