A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
18 Years
N/A
Female
Endometrial Cancer
Trial Information
A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Outcome Time Frame:
Average expected time of 12 weeks
Safety Issue:
No
Principal Investigator
Pamela Paley, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Swedish Medical Center
Authority:
United States: Institutional Review Board
Study ID:
IR 5197
NCT ID:
NCT01562106
Start Date:
February 2012
Completion Date:
February 2015
Related Keywords:
- Endometrial Cancer
- Cancer of Endometrium
- Cancer of the Endometrium
- Carcinoma of Endometrium
- Endometrial Carcinoma
- Endometrium Cancer
- Neoplasms, Endometrial
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|---|
| Pacific Gynecology Specialists | Seattle, Washington 98104 |
| Swedish Medical Center | Seattle, Washington 98122-4307 |
| Swedish Medical Center Issaquah Campus | Issaquah, Washington 98027 |
