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

Not Applicable

• Conditions: Endometriosis
• Interventions: Device: NIRF imaging

• Registration Number: NCT03017989
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIRF imaging	NIRF imaging	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

Primary Outcome Measures

Name	Time	Method
Number of detected endometriotic lesions with Near Infrared Light versus with white light	during surgery	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.

Secondary Outcome Measures

Name	Time	Method
Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye	during surgery	Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
Histological assessment of taken biopsies: assessment of localization of ICG uptake	biopsies taken during surgery, which are assessed during the 1th week after surgery	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 measurement	during the laparoscopic procedure	measuring the total operating time, and the extra time needed for fluorescence imaging
Satisfaction of the surgeon with the technique	immediately after surgery	Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.
Histological assessment of taken biopsies: assessment Target to background ratio	biopsies taken during surgery, which are assessed during the 1th week after surgery	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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands