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

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

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 Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Device: NIRF imaging

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: NIRF imaging; 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.; Other Names: Near infrared fluorescence imaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Laurents Stassen, M.D, Ph.D, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Indocyanine green (ICG); Near Infrared Fluorescence Imaging
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: NL54458.068.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No