Endometrial Cancer
Conditions
Keywords
Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
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.
Interventions
PROCEDUREFluorescence-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.
Sponsors
Swedish Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer. | Average expected time of 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed