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

NCT05004623 | Completed

• 1 other identifier: 45814621.5.0000.5201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Keywords

Sentinel Lymph Node Biopsy; Fluorescence; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• The ability to detect sentinel lymph nodes.

  The ability to detect at least one sentinel lymph node per patient during open surgeries.

  Intraoperativelly

Study Arms (1)

Sentinel Lymph Node Biopsy

OTHER

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

Interventions

Sentinel Lymph Node Biopsy DEVICE

Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.

Sentinel Lymph Node Biopsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

IMIP - Instituo de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Thales P Batita, PhD

  IMIP, Department of Surgery/Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting

Model Details: This is an early feasibility study.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 13, 2021
• Study Start: May 26, 2021
• Primary Completion: July 27, 2021
• Study Completion: August 6, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)