NL-OMON50918
Recruiting
Not Applicable
Fluorescence guided surgery for intra-operative detection of meningioma using Bevacizumab-IRDye800CW - Fluorescence guided surgery of meningioma using Bevacizumab-800CW (LUMINA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 19
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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