Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy

NCT03332004 | Completed Phase 2

• 1 other identifier: GRE-Endo
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation

Conditions

Pelvic Endometriosis; Endometriosis Outside Pelvis

Keywords

Indocyanine Green; Deep Infiltrating Endometriosis; Near-Infrared Vision; Occult endometriosis; Invisible endometriosis

Outcome Measures

Primary Outcomes (1)

• Detection of endometriotic lesions

  Optical qualitative assessment through the visual evaluation of a single expert surgeon (presence / absence of fluorescence, due to the injection of the Indocyanine Green and the use of the Near Infrared vision, at the level the of suspected endometriotic lesions)

  Intraoperative

Secondary Outcomes (4)

• Localization of occult endometriotic lesion

  Intraoperative

• Operatory Time

  Intraoperative

• Complications

  From operatory room up to 3 days

• Side effects

  From operatory room up to 3 days

Study Arms (1)

Indocyanine Green arm

EXPERIMENTAL

All the enrolled patients met the inclusion criteria. No patients have been excluded from the study. All patient have been subjected, during laparoscopy, to an accurate inspection of the abdomen and all the visible endometriotic lesions have been described. Subsequently, 0.25 mg /(kg BW) Indocyanine Green were administered intravenously during surgery and a second look of the abdomen and pelvis with the Near Infrared Vision has been made, in order to identify the fluorescent lesions. All the lesions has been described and localized pre and post the Indocyanine Green injection and then removed and properly cataloged

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously

Indocyanine Green arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suspected endometriosis with necessity for laparoscopic confirmation and resection
• Regular menstrual cycles

You may not qualify if:

• Patients younger than 18 years and older than 50 years at time of operation
• Subject with previous history of adverse reaction or allergy to Indocyanine Green, iodine, shellfish or iodine dyes
• Documented allergy to sulfur containing compounds
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Indocyanine Green
• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (Total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal)
• Subject has uremia, serum creatinine (\> 2.0 mg/dl)
• Subject has severe coronary heart disease (instable angina pectoris)
• Pregnant or breast-feeding women
• Subject actively participating in another drug, biologic and/or device protocol
• The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
• Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Giovanni Scambia

  Division of Oncologic Gynecology, Fondazione Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In the selected patients, after a first white light visual inspection, 0.25 mg/(kg BW) ICG were injected intravenously. After 5 to 30 minutes a second inspection of the abdomen and pelvis in Near Infrared vision was made. All the visualized lesions were carefully described pre and post the Indocyanine Green injection, removed and listed

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 6, 2017
• Study Start: January 4, 2016
• Primary Completion: February 16, 2017
• Study Completion: February 16, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

IT (1)