ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis
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|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
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Device: NIRF imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Time measurement [ Time Frame: during the laparoscopic procedure ]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 [ Time Frame: during surgery ]Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
- 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.
- 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.
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
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6202|
|Principal Investigator:||Laurents Stassen, M.D, Ph.D||Maastricht University Medical Center|