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

NCT03017989 | Unknown DMC

• 1 other identifier: NL54458.068.15
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Near Infrared Fluorescence Imaging; Indocyanine green (ICG)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Histological assessment of taken biopsies: assessment of localization of ICG uptake

  biopsies taken during surgery, which are assessed during the 1th week after surgery

• Time measurement

  during the laparoscopic procedure

• Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye

  during surgery

• Satisfaction of the surgeon with the technique

  immediately after surgery

• Histological assessment of taken biopsies: assessment Target to background ratio

  biopsies taken during surgery, which are assessed during the 1th week after surgery

Study Arms (1)

NIRF imaging

EXPERIMENTAL

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

Interventions

NIRF imaging 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.

Also known as: Near infrared fluorescence imaging

NIRF imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202, Netherlands

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laurents Stassen, M.D, Ph.D

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

NL (1)