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

Maastricht University Medical Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endometriosis

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: during surgery

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.