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

Uterine Cervical Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004623
• Other study ID #: 45814621.5.0000.5201
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: August 6, 2021

Study information

• Verified date: August 2021
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 6, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Device:
• Sentinel Lymph Node Biopsy
Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.

Locations

Country	Name	City	State
Brazil	IMIP - Instituo de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability to detect sentinel lymph nodes.	The ability to detect at least one sentinel lymph node per patient during open surgeries.	Intraoperativelly