Clinical trial NCT01562106: Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Cancer of Endometrium
Cancer of the Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma
Endometrium Cancer
Neoplasms, Endometrial
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
timeFrame: Average expected time of 12 weeks
Secondary outcomes:
measure: Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
timeFrame: Average expected time of 12 weeks
Other outcomes:
Locations:
city: Issaquah
country: United States
facility: Swedish Medical Center Issaquah Campus
state: Washington
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Pamela Paley, MD
role: PRINCIPAL_INVESTIGATOR
References: