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

niversity Medical Center Groningen0 个研究点目标入组 19 人开始时间: 2021年5月18日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 19
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 19

•- 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).

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