Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
This study is currently recruiting participants.
Verified November 2012 by Swedish Medical Center
Sponsor:
Swedish Medical Center
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01562106
First received: March 21, 2012
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endometrial Cancer |
Procedure: Fluorescence-guided sentinel lymph node detection |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Swedish Medical Center:
Primary Outcome Measures:
- Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer. [ Time Frame: Average expected time of 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation. [ Time Frame: Average expected time of 12 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ICG Dye
Fluorescence-guided sentinel lymph node detection
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562106
Contacts
| Contact: Pamela Paley, MD | (206) 965-1700 | ppaley@pacificgyn.com |
Locations
| United States, Washington | |
| Swedish Medical Center Issaquah Campus | Recruiting |
| Issaquah, Washington, United States, 98027 | |
| Contact: Pamela Paley, MD 206-965-1700 ppaley@pacific.gyn | |
| Principal Investigator: Pamela Paley, MD | |
| Sub-Investigator: Dan Veljovich, MD | |
| Sub-Investigator: Chirag Shah, MD | |
| Sub-Investigator: Christina Isacson, MD | |
| Swedish Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Pamela Paley, MD 206-965-1700 ppaley@pacificgyn.com | |
| Principal Investigator: Pamela Paley, MD | |
| Sub-Investigator: Dan Veljovich, MD | |
| Sub-Investigator: Chirag Shah, MD | |
| Sub-Investigator: Christina Isacson, MD | |
| Pacific Gynecology Specialists | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Pamela Paley, MD 206-965-1700 ppaley@pacificgyn.com | |
| Principal Investigator: Pamela Paley, MD | |
| Sub-Investigator: Dan Veljovich, MD | |
| Sub-Investigator: Chirag Shah, MD | |
Sponsors and Collaborators
Swedish Medical Center
Investigators
| Principal Investigator: | Pamela Paley, MD | Swedish Medical Center |
More Information
No publications provided
| Responsible Party: | Swedish Medical Center |
| ClinicalTrials.gov Identifier: | NCT01562106 History of Changes |
| Other Study ID Numbers: | IR 5197 |
| Study First Received: | March 21, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Swedish Medical Center:
|
Cancer of Endometrium Cancer of the Endometrium Carcinoma of Endometrium |
Endometrial Carcinoma Endometrium Cancer Neoplasms, Endometrial |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 19, 2013