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Diagnostic Value of ICG in Endometriosis

Primary Purpose

Endometriosis, Laparoscopy, Near Infrared Fluorescence Imaging

Status
Completed
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Arm, ICG and NIR imaging

Arm 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.

Outcomes

Primary Outcome Measures

Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
January 13, 2020
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03850158
Brief Title
Diagnostic Value of ICG in Endometriosis
Official Title
Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Laparoscopy, Near Infrared Fluorescence Imaging, Indocyanine Green (ICG)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm, ICG and NIR imaging
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
Description
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.
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Imboden, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31943126
Citation
Siegenthaler F, Knabben L, Mohr S, Nirgianakis K, Imboden S, Mueller MD. Visualization of endometriosis with laparoscopy and near-infrared optics with indocyanine green. Acta Obstet Gynecol Scand. 2020 May;99(5):591-597. doi: 10.1111/aogs.13803. Epub 2020 Jan 28.
Results Reference
derived

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Diagnostic Value of ICG in Endometriosis

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