Early Feasibility Study of the Easy Light Fluorecence Imaging System

Study Overview
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Brief Summary
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This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.

Detailed Description
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This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light.

Official Title
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Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers

Conditions
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Uterine Cervical Neoplasms, Uterine Neoplasms

Intervention / Treatment
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* Device: Sentinel Lymph Node Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proven cervical or uterine cancers; Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics; Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant; Performance status of 0-2; No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery; Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding; Appropriated cardio-respiratory, hepato-renal and hematological reserves; Signing of the Consent Form. Exclusion Criteria: 1. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: This is an early feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sentinel Lymph Node Biopsy<br>Sentinel lymph node biopsy by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. Lymph node dissection in each hemipelvis should be performed as standard if no sentinel lymph node is detected. Decision of proceeding with complementary lymph node dissection after sentinel lymph node detection is a surgeon decision, according to his/her usual practice. | Device: Sentinel Lymph Node Biopsy<br>* Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to detect sentinel lymph nodes. | The ability to detect at least one sentinel lymph node per patient during open surgeries. | Intraoperativelly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green