Clinical trial NCT03017989: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Keywords: Near Infrared Fluorescence Imaging
Indocyanine green (ICG)
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of detected endometriotic lesions with Near Infrared Light versus with white light
timeFrame: during surgery
Secondary outcomes:
measure: Histological assessment of taken biopsies: assessment of localization of ICG uptake
timeFrame: biopsies taken during surgery, which are assessed during the 1th week after surgery
measure: Time measurement
timeFrame: during the laparoscopic procedure
measure: Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
timeFrame: during surgery
measure: Satisfaction of the surgeon with the technique
timeFrame: immediately after surgery
measure: Histological assessment of taken biopsies: assessment Target to background ratio
timeFrame: biopsies taken during surgery, which are assessed during the 1th week after surgery
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Laurents Stassen, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: