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

Not Applicable

Completed

• Conditions: Endometrial Cancer; Sentinel Lymph Node Detection
• Interventions: Procedure: ICG Dye

• Registration Number: NCT02131558
• Lead Sponsor: Lahey Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-07
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Primary Completion: 2017-03-08
• Study Completion: 2017-03-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Detection of sentinel lymph node(s)	Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant	The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.

Secondary Outcome Measures

Name	Time	Method
Comparison between sentinel node status for disease and non-sentinel node disease status	Following surgery and pathological evaluation of all removed nodes, up to "1 year"	The pathological evaluation of the sentinel lymph nodes (positive or negative) will be compared to the status of the non-sentinel nodes removed to determine whether the sentinel nodes accurately reflected the same status as the non-sentinel nodes.

Trial Locations

Locations (1)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States