Back to resultsEarly Feasibility Study of the "Easy Light" Fluorecence Imaging System
Primary Purpose
Uterine Cervical Neoplasms, Uterine Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sentinel Lymph Node Biopsy
Sponsored by
About this trial
This is an interventional device feasibility trial for Uterine Cervical Neoplasms focused on measuring Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green
Eligibility Criteria
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.
Sites / Locations
- IMIP - Instituo de Medicina Integral Professor Fernando Figueira
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sentinel Lymph Node Biopsy
Arm Description
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.
Outcomes
Primary Outcome Measures
The ability to detect sentinel lymph nodes.
The ability to detect at least one sentinel lymph node per patient during open surgeries.
Secondary Outcome Measures
Full Information
NCT ID
NCT05004623
First Posted
June 16, 2021
Last Updated
August 9, 2021
Sponsor
Professor Fernando Figueira Integral Medicine Institute
1. Study Identification
Unique Protocol Identification Number
NCT05004623
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Uterine Neoplasms
Keywords
Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an early feasibility study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sentinel Lymph Node Biopsy
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sentinel Lymph Node Biopsy
Intervention Description
Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.
Primary Outcome Measure Information:
Title
The ability to detect sentinel lymph nodes.
Description
The ability to detect at least one sentinel lymph node per patient during open surgeries.
Time Frame
Intraoperativelly
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thales P Batita, PhD
Organizational Affiliation
IMIP, Department of Surgery/Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMIP - Instituo de Medicina Integral Professor Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Feasibility Study of the "Easy Light" Fluorecence Imaging System
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