This trial is active, not recruiting.

Condition endometrial cancer
Treatment fluorescence-guided sentinel lymph node detection
Sponsor Swedish Medical Center
Start date February 2012
End date September 2015
Trial size 130 participants
Trial identifier NCT01562106, IR 5197


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Fluorescence-guided sentinel lymph node detection
fluorescence-guided sentinel lymph node detection
During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Pamela Paley, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Swedish Medical Center.