Clinical trial NCT03332004: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Endometriosis
Endometriosis Outside Pelvis
Keywords: Indocyanine Green
Deep Infiltrating Endometriosis
Near-Infrared Vision
Occult endometriosis
Invisible endometriosis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection of endometriotic lesions
timeFrame: Intraoperative
Secondary outcomes:
measure: Localization of occult endometriotic lesion
timeFrame: Intraoperative
measure: Operatory Time
timeFrame: Intraoperative
measure: Complications
timeFrame: From operatory room up to 3 days
measure: Side effects
timeFrame: From operatory room up to 3 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
name: Giovanni Scambia
role: PRINCIPAL_INVESTIGATOR
References: