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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Endometriosis

Treatments: Device: NIRF imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03017989

NL54458.068.15

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

NIRF imaging

Experimental group

Description:

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

Treatment:

Device: NIRF imaging