Back to resultsICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis
Primary Purpose
Endometriosis
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NIRF imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis focused on measuring Near Infrared Fluorescence Imaging, Indocyanine green (ICG)
Eligibility 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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIRF imaging
Arm Description
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
Outcomes
Primary Outcome Measures
Number of detected endometriotic lesions with Near Infrared Light versus with white light
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
Histological assessment of taken biopsies: assessment of localization of ICG uptake
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.
Time measurement
measuring the total operating time, and the extra time needed for fluorescence imaging
Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
Satisfaction of the surgeon with the technique
Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.
Histological assessment of taken biopsies: assessment Target to background ratio
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.
Full Information
NCT ID
NCT03017989
First Posted
January 3, 2017
Last Updated
March 6, 2019
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03017989
Brief Title
ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis
Official Title
The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Near Infrared Fluorescence Imaging, Indocyanine green (ICG)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIRF imaging
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
NIRF imaging
Other Intervention Name(s)
Near infrared fluorescence imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of detected endometriotic lesions with Near Infrared Light versus with white light
Description
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.
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Histological assessment of taken biopsies: assessment of localization of ICG uptake
Description
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.
Time Frame
biopsies taken during surgery, which are assessed during the 1th week after surgery
Title
Time measurement
Description
measuring the total operating time, and the extra time needed for fluorescence imaging
Time Frame
during the laparoscopic procedure
Title
Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
Description
Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
Time Frame
during surgery
Title
Satisfaction of the surgeon with the technique
Description
Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.
Time Frame
immediately after surgery
Title
Histological assessment of taken biopsies: assessment Target to background ratio
Description
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.
Time Frame
biopsies taken during surgery, which are assessed during the 1th week after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurents Stassen, M.D, Ph.D
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis
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