ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis

Study Overview
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Brief Summary
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Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.

Official Title
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The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Device: NIRF imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected Able to understand the nature of the study and what will be required of them Females Age >18years Premenopausal No history of impaired liver and renal function No history of hypersensitivity or allergy to indocyanine green or iodide No hyper-thyroidism or autonomic thyroid adenomas Willing to participate Exclusion Criteria: Not able to give written informed consent Males Aged < 18 years Pregnant or breast-feeding women Known hypersensitivity or allergy to indocyanine green or iodide Known hyper-thyroidism or autonomic thyroid adenomas Not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRF imaging<br>After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics | Device: NIRF imaging<br>* By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding.<br>* Other names: Near infrared fluorescence imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of detected endometriotic lesions with Near Infrared Light versus with white light | The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light. | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological assessment of taken biopsies: assessment of localization of ICG uptake | Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes. | biopsies taken during surgery, which are assessed during the 1th week after surgery | 
| Time measurement | measuring the total operating time, and the extra time needed for fluorescence imaging | during the laparoscopic procedure | 
| Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye | Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here. | during surgery | 
| Satisfaction of the surgeon with the technique | Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure. | immediately after surgery | 
| Histological assessment of taken biopsies: assessment Target to background ratio | The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes. | biopsies taken during surgery, which are assessed during the 1th week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near Infrared Fluorescence Imaging, Indocyanine green (ICG)