NL-OMON25431招募中不适用

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 个研究点目标入组 19 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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.

•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.

发起方

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