Endometriosis
Conditions
Interventions
Three days before surgery, the patient receives an intravenous injection of 4,5
mg bevacizumab-800CW. During laparoscopy, white light and fluorescence images
are taken with the Olympus NIR camera sy
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Females aged * 18 years 2. Scheduled for surgery for the treatment of endometriosis 3. WHO performance score of 0-2 4. Written informed consent For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: 4. A negative serum pregnancy test prior to receiving the second generation tracer 5. Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent ;2. Pregnancy 3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies 4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this feasibility study is to investigate whether the fluorescent agent bevacizumab-800CW can specifically target endometriosis lesions as determined by ex vivo fluorescence imaging techniques. This will be confirmed by standard H/E staining, VEGF immunohistochemistry, confocal laser endomicroscopy (CLE), spectroscopy and histopathological fluorescence microscopy. In this way, future intra-operative quantification and visualisation of endometriosis can be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to investigate whether the Olympus NIRlaparoscope is able to detect endometriosis lesions intraoperatively by fluorescence imaging after micro dosing injection of 4,5 mg bevacizumab-800CW. | — |
Countries
Netherlands
Outcome results
None listed