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Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

NCT ID: NCT01562106

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Endometrial Cancer

Keywords

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Cancer of Endometrium Cancer of the Endometrium Carcinoma of Endometrium Endometrial Carcinoma Endometrium Cancer Neoplasms, Endometrial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICG Dye

Fluorescence-guided sentinel lymph node detection

Group Type EXPERIMENTAL

Fluorescence-guided sentinel lymph node detection

Intervention Type PROCEDURE

During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Paley, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Locations

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Swedish Medical Center Issaquah Campus

Issaquah, Washington, United States

Site Status

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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IR 5197

Identifier Type: -

Identifier Source: org_study_id