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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03017989
• Other study ID #: NL54458.068.15
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2019

Study information

• Verified date: March 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: September 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time measurement	measuring the total operating time, and the extra time needed for fluorescence imaging	during the laparoscopic procedure
Secondary	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
Secondary	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
Secondary	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