Fluorescence imaging of meningioma tissue during an operatio

Phase 1

• Conditions: meningioma; MedDRA version: 21.1Level: PTClassification code 10027191Term: MeningiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-006141-19-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 19

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.
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

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 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified