Early Feasibility Study of the "Easy Light" Fluorecence Imaging System

Not Applicable

Completed

• Conditions: Uterine Cervical Neoplasms; Uterine Neoplasms
• Interventions: Device: Sentinel Lymph Node Biopsy

• Registration Number: NCT05004623
• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-05-26
• Study First Submitted: 2021-06-16
• Primary Completion: 2021-07-27
• Status Verified: 2021-08
• Study Completion: 2021-08-06
• Study First Submitted QC: 2021-08-09
• Last Update Submitted: 2021-08-09
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

1. Patients with biopsy-proven cervical or uterine cancers;
2. Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
3. Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
4. Performance status of 0-2;
5. No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
6. Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding;
7. Appropriated cardio-respiratory, hepato-renal and hematological reserves;
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Biopsy	Sentinel Lymph Node Biopsy	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.

Primary Outcome Measures

Name	Time	Method
The ability to detect sentinel lymph nodes.	Intraoperativelly	The ability to detect at least one sentinel lymph node per patient during open surgeries.

Trial Locations

Locations (1)

IMIP - Instituo de Medicina Integral Professor Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil