Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562106
• Other study ID #: IR 5197
• Status: Completed
• Phase: N/A
• First received: March 21, 2012
• Last updated: November 16, 2016
• Start date: February 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Fluorescence-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.

Locations

Country	Name	City	State
United States	Swedish Medical Center Issaquah Campus	Issaquah	Washington
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.		Average expected time of 12 weeks	No
Secondary	Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.	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.	Average expected time of 12 weeks	No