Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
1 other identifier
interventional
123
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 18, 2016
November 1, 2016
3.6 years
March 21, 2012
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Average expected time of 12 weeks
Secondary Outcomes (1)
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
Average expected time of 12 weeks
Study Arms (1)
ICG Dye
EXPERIMENTALFluorescence-guided sentinel lymph node detection
Interventions
During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Swedish Medical Center Issaquah Campus
Issaquah, Washington, 98027, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Paley, MD
Swedish Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2015
Study Completion
August 1, 2016
Last Updated
November 18, 2016
Record last verified: 2016-11