Diagnostic Value of ICG in Endometriosis

Early Phase 1

Completed

• Conditions: Endometriosis; Near Infrared Fluorescence Imaging; Indocyanine Green (ICG); Laparoscopy
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT03850158
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.

Detailed Description

Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Primary Completion: 2019-11
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

• Informed Consent as documented by signature
• Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
• Patients should be in follicular phase
• Have chronic pelvic pain and/or Infertility and be willing to undergo planned endometriosis resection procedure.

Exclusion Criteria

• Known or suspected allergy to iodine, shellfish, or ICG dye
• Hyperthyroidism
• Severe renal insufficiency
• Simultaneous therapy with beta-blockers
• Women who are pregnant (positive HCG in the blood) or breast feeding
• Intention to become pregnant during the course of the study
• Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia)
• Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated markers of infection in the blood)
• Previous history of radiation therapy of the pelvis
• Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Arm, ICG and NIR imaging	Indocyanine Green	NIR fluorescence imaging is performed after white light laparoscopy. 0.3mg/kg bodyweight of ICG is administered i.v. All suspected lesions are removed and labeled whether they are seen in WL or NIR imaging or both. Evaluation is performed after the histological analysis of the lesions.

Primary Outcome Measures

Name	Time	Method
Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy	The duration of the participation is from the signature of the informed consent until the end of the hospitalisation, expected to be on average after 2 to 4 days	The number of histologically proven endometriotic lesions detected with NIR fluorescence imaging are compared to the number of lesions detected with white light laparoscopy alone and white light laparoscopy plus NIR fluorescence imaging.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital; 🇨🇭 Bern, Switzerland