Diagnostic Value of ICG in Endometriosis

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Early Phase 1

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

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT03850158

Study ID 3300

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Interventional Arm, ICG and NIR imaging

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green