Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Swedish Medical Center

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: Fluorescence-guided sentinel lymph node detection

Study type: Interventional

Funder types: Other

Identifiers

NCT01562106

IR 5197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

ICG Dye

Experimental group

Description:

Fluorescence-guided sentinel lymph node detection

Treatment:

Procedure: Fluorescence-guided sentinel lymph node detection