Determine the feasibility of detecting endometriosis during surgery using a molecular targeted fluorescent imaging tracer

Completed

Conditions: Endometriosis
10038595
10029903

Registration Number: NL-OMON46122

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this feasibility study is to investigate whether the fluorescent<br /><br>agent bevacizumab-800CW can specifically target endometriosis lesions as<br /><br>determined by ex vivo fluorescence imaging techniques. This will be confirmed<br /><br>by standard H/E staining, VEGF immunohistochemistry, confocal laser<br /><br>endomicroscopy (CLE), spectroscopy and histopathological fluorescence<br /><br>microscopy. In this way, future intra-operative quantification and<br /><br>visualisation of endometriosis can be evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is to investigate whether the Olympus<br /><br>NIRlaparoscope is able to detect endometriosis lesions intraoperatively by<br /><br>fluorescence imaging after micro dosing injection of 4,5 mg bevacizumab-800CW.</p><br>