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

Recruiting

Conditions: Intracranial meningioma

Registration Number: NL-OMON25431

Lead Sponsor: Department of Neurosurgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 19

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Has been injected with another Investigational Medicinal Product (IMP) within the past month;
- Concomitant malignancies, including metastasized colon-, rectal-, breast carcinoma, non-small cellular lung carcinoma (NSCLC); primary epithelial ovarian-, falopian tube-, primary peritoneal- or cervical carcinoma. 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). These patients will also undergo a pregnancy test prior to tracer administration.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Optimal dose of Bevacizumab-IRDye800CW in meningioma surgery<br>One of the primary objectives of this pilot study is to determine the optimal dose of Bevacizumab-IRDye800CW for an adequate TBR in intracranial meningioma surgery. The ex vivo TBR will be used as primary endpoint. For that purpose, explorative statistics will be applied. The differences between paired and unpaired data will be tested using a Wilcoxon test and Mann-Whitney test respectively. Data will be presented as median values with interquartile ranges. For statistical analysis and graph design, GraphPad Prism will be used.<br><br>- Safety aspects of administration Bevacizumab-IRDye800CW<br>Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reaction (SUSAR) related to the use of Bevacizumab-IRDye800CW.

Secondary Outcome Measures

Name	Time	Method
- Correlation of ex vivo fluorescent signal in meningioma and normal tissue with histopathology and immunohistochemistry. <br>- Quantification of fluorescent signal by spectroscopy. <br>- Ability to detect the in vivo (intra-operative) fluorescent signal in meningioma and normal tissue using the Zeiss Pentero with IR800 fluorescence module (operative microscope/optic device), and the Yoda (fluorescence camera system). <br>- Macroscopic quantification of the fluorescent signal of pathological confirmed meningioma.