NL-OMON50918招募中不适用
Fluorescence guided surgery for intra-operative detection of meningioma using Bevacizumab-IRDye800CW - Fluorescence guided surgery of meningioma using Bevacizumab-800CW (LUMINA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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.
排除标准
- •- 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).
研究者
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