NL-OMON25431
Recruiting
Not Applicable
Fluorescence guided surgery for intra-operative detection of meningioma using Bevacizumab-IRDye800CW: A single center phase I/II study
Department of Neurosurgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen0 sites19 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Neurosurgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen
- Enrollment
- 19
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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