Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: Fluorescence-guided sentinel lymph node detection

• Registration Number: NCT01562106
• Lead Sponsor: Swedish Medical Center

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Primary Completion: 2015-09
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG Dye	Fluorescence-guided sentinel lymph node detection	Fluorescence-guided sentinel lymph node detection

Primary Outcome Measures

Name	Time	Method
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.	Average expected time of 12 weeks

Secondary Outcome Measures

Name	Time	Method
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.	Average expected time of 12 weeks	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.

Trial Locations

Locations (3)

Pacific Gynecology Specialists; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center Issaquah Campus; 🇺🇸 Issaquah, Washington, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States