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

NCT ID: NCT03017989

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-09-30

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

NIRF imaging

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Near infrared fluorescence imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurents Stassen, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL54458.068.15

Identifier Type: -

Identifier Source: org_study_id