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

niversity Medical Center Groningen0 sites19 target enrollmentMay 18, 2021

Overview

No summary available.

Registry

who.int

Start Date

May 18, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•\- 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).