Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-03-08

Brief Summary

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Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.

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Detailed Description

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Conditions

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Endometrial Cancer Sentinel Lymph Node Detection

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

Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging.

Group Type EXPERIMENTAL

ICG Dye

Intervention Type PROCEDURE

ICG Dye injections

Interventions

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ICG Dye

ICG Dye injections

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult women patients (\>18 years of age and \<90 years of age)
* Research authorization (consent)
* Pre-operative diagnosis of clinical Stage 1 endometrial cancer
* Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
* Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy

Exclusion Criteria

* Severe coagulopathy or severe thrombocytopenia
* Severe anemia
* Severe cardio-pulmonary comorbidities demanding minimization of operative time
* History of liver disease
* Iodide allergy
* Emergent operation
* Additional surgical risk as determined during surgery at the discretion of the attending
* Impaired capacity to make informed medical decisions

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No