Clinical trial NCT05004623: Early Feasibility Study of the "Easy Light" Fluorecence Imaging System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Uterine Neoplasms
Keywords: Sentinel Lymph Node Biopsy
Fluorescence
Indocyanine Green
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an early feasibility study.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The ability to detect sentinel lymph nodes.
timeFrame: Intraoperativelly
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP - Instituo de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
affiliation: IMIP, Department of Surgery/Oncology
name: Thales P Batita, PhD
role: PRINCIPAL_INVESTIGATOR
References: