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

Endometriosis Outside Pelvis Clinical Trial

Official title:

Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332004
• Other study ID #: GRE-Endo
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2017
• Last updated: November 1, 2017
• Start date: January 4, 2016
• Est. completion date: February 16, 2017

Study information

• Verified date: November 2017
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 16, 2017
• Est. primary completion date: February 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Outside Pelvis
• Pelvic Endometriosis

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Intraoperative
Secondary	Operatory Time	To assess if the use of Indocyanine Green cause a significant increase of the operatory time	Intraoperative
Secondary	Complications	To assess if the use of Indocyanine Green increase the percentage of intra and post-operative complications	From operatory room up to 3 days
Secondary	Side effects	Evaluation of possible side effects related to the use of Indocyanine Green as a fluorescent endometriosis' marker	From operatory room up to 3 days