Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

Completed · Not applicable

Conditions studied: Endometrial Cancer

In brief

The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H\&E pathologic analysis.

Key facts

Study ID

NCT02068820

Run by

AdventHealth

People needed

200

Starts

2012-09-01

Expected to finish

2015-01-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The patient must be ≥18 and ≤85 years of age.
• The patient must be female.
• The patient must be willing and able to provide informed consent.
• The patient is willing and able to comply with the study protocol.
• The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy.
• The patient agrees to follow-up examinations out to 6-weeks post-treatment

You may not qualify if…

• The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy.
• The patient has known or suspected allergies to iodine, ICG or ISB.
• The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)

Where it is running

• Florida Hospital Gynecologic Oncology — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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