Diagnostic Value of ICG in Endometriosis

January 13, 2020 updated by: University Hospital Inselspital, Berne

Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm, ICG and NIR imaging
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.
Drug: Indocyanine Green
Indocyanine green is administered intra-venous after dilution with water in a peripheral vein at a dosage of 0.3mg/kg body weight as a bolus injection. The injection will take place during surgery. By using NIR fluorescence imaging ICG is made visible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Sara Imboden, MD, Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study ID 3300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Indocyanine Green

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe