Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017989
Recruitment Status : Unknown
Verified March 2019 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Endometriosis Device: NIRF imaging Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIRF imaging
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
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.
Other Name: Near infrared fluorescence imaging




Primary Outcome Measures :
  1. Number of detected endometriotic lesions with Near Infrared Light versus with white light [ Time Frame: during surgery ]
    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.


Secondary Outcome Measures :
  1. Histological assessment of taken biopsies: assessment of localization of ICG uptake [ Time Frame: biopsies taken during surgery, which are assessed during the 1th week after surgery ]
    Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes.

  2. Time measurement [ Time Frame: during the laparoscopic procedure ]
    measuring the total operating time, and the extra time needed for fluorescence imaging

  3. Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye [ Time Frame: during surgery ]
    Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.

  4. Satisfaction of the surgeon with the technique [ Time Frame: immediately after surgery ]
    Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.

  5. Histological assessment of taken biopsies: assessment Target to background ratio [ Time Frame: biopsies taken during surgery, which are assessed during the 1th week after surgery ]
    The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017989


Locations
Layout table for location information
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Laurents Stassen, M.D, Ph.D Maastricht University Medical Center
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03017989    
Other Study ID Numbers: NL54458.068.15
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Near Infrared Fluorescence Imaging
Indocyanine green (ICG)
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis