Back to resultsNear-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
Primary Purpose
Pelvic Endometriosis, Endometriosis Outside Pelvis
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Endometriosis focused on measuring Indocyanine Green, Deep Infiltrating Endometriosis, Near-Infrared Vision, Occult endometriosis, Invisible endometriosis
Eligibility Criteria
Inclusion Criteria:
- Suspected endometriosis with necessity for laparoscopic confirmation and resection
- Regular menstrual cycles
Exclusion Criteria:
- 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
Sites / Locations
- Catholic University of Sacred Heart
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indocyanine Green arm
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Localization of occult endometriotic lesion
To detect occult endometriotic lesions, thanks to the fluorescence of the Indocyanine Green, that would remain otherwise not visible to the surgeon eye
Operatory Time
To assess if the use of Indocyanine Green cause a significant increase of the operatory time
Complications
To assess if the use of Indocyanine Green increase the percentage of intra and post-operative complications
Side effects
Evaluation of possible side effects related to the use of Indocyanine Green as a fluorescent endometriosis' marker
Full Information
NCT ID
NCT03332004
First Posted
October 12, 2017
Last Updated
November 1, 2017
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT03332004
Brief Title
Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
Official Title
Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
February 16, 2017 (Actual)
Study Completion Date
February 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria.
The first abdominal and pelvi's inspection was made using direct laparoscope visualization under white light conditions. All areas suspected of peritoneal endometriosis were classified as white, black and red lesions and recorded together with their anatomic location in the surgical record for the purposes of subsequent extirpation.
After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW) Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green imaging mode were recorded with their corresponding appearance in white light mode.
If suspected areas were visible either in white light or Indocyanine Green imaging mode, specific sample has been taken from these areas.
In addition control biopsy specimens from inconspicuous peritoneum has been taken.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Endometriosis, Endometriosis Outside Pelvis
Keywords
Indocyanine Green, Deep Infiltrating Endometriosis, Near-Infrared Vision, Occult endometriosis, Invisible endometriosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine Green arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously
Primary Outcome Measure Information:
Title
Detection of endometriotic lesions
Description
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)
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Localization of occult endometriotic lesion
Description
To detect occult endometriotic lesions, thanks to the fluorescence of the Indocyanine Green, that would remain otherwise not visible to the surgeon eye
Time Frame
Intraoperative
Title
Operatory Time
Description
To assess if the use of Indocyanine Green cause a significant increase of the operatory time
Time Frame
Intraoperative
Title
Complications
Description
To assess if the use of Indocyanine Green increase the percentage of intra and post-operative complications
Time Frame
From operatory room up to 3 days
Title
Side effects
Description
Evaluation of possible side effects related to the use of Indocyanine Green as a fluorescent endometriosis' marker
Time Frame
From operatory room up to 3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected endometriosis with necessity for laparoscopic confirmation and resection
Regular menstrual cycles
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Scambia
Organizational Affiliation
Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
We'll reach out to this number within 24 hrs