Fluorescence guided surgery for intra-operative detection of meningioma using Bevacizumab-IRDye800CW

Recruiting

Conditions: meningioma
10029209

Registration Number: NL-OMON50918

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 19

Inclusion Criteria

- Age >= 18 years;
- Patients with convexity or sphenoid wing meningioma determined by
preoperative imaging, e.g. MRI and/or CT;
- Scheduled to undergo elective resection at the UMCG as part of the standard
preoperative work- up;
- Mentally competent person who is able and willing to comply with study
procedures;
- Signed written informed consent.

Exclusion Criteria

- Has been injected with another Investigational Medicinal Product (IMP) within
the past month;
- Concomitant malignancies, except for adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with
prior malignancies must be disease-free for at least five years;
- Previous allergic reaction to Bevacizumab;
- Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent;
- Pregnant or lactating women. During standard of care, pregnancy is a
contraindication for elective (neuro)surgical procedures. Therefore, the
possibility of pregnancy will be discussed with women of childbearing potential
(defined as premenopausal women with intact reproductive organs and women less
than two years after menopause).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Determine the optimal dose of Bevacizumab-IRDye800CW for an adequate<br /><br>tumor-to-background ratio (TBR) ex vivo in intracranial meningioma.<br /><br>- Determine the safety profile of up to 25mg Bevacizumab-IRDye800CW in<br /><br>meningioma patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Correlate and validate ex vivo fluorescence signals with histopathology and<br /><br>immunohistochemistry.<br /><br>- Determine the suitability of currently available intraoperative systems<br /><br>(Zeiss Pentero and the Yoda).<br /><br>- Quantify sensitivity and specificity of Bevacizumab-IRDye800CW for meningioma<br /><br>in order to make a power size calculation for a possible subsequent diagnostic<br /><br>accuracy study.</p><br>