meningioma MedDRA version: 21.1 Level: PT Classification code 10027191 Term: Meningioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bevacizumab-IRDye800CW
Product Code: Bevacizumab-IRDye800CW
Pharmaceutical Form: Suspension for injection
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion 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. 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - One of the primary objectives of this pilot study is to determine the optimal dose of Bevacizumab-IRDye800CW for an adequate TBR in intracranial meningioma surgery. The ex vivo TBR will be used as primary endpoint. - Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reaction (SUSAR) related to the use of Bevacizumab-IRDye800CW. ;Secondary Objective: - Correlation of ex vivo fluorescent signal in meningioma and normal tissue with histopathology and immunohistochemistry. - Quantification of fluorescent signal by spectroscopy. - Ability to detect the in vivo (intra-operative) fluorescent signal in meningioma and normal tissue using the Zeiss Pentero with IR800 fluorescence module, and the Yoda. - Macroscopic quantification of the fluorescent signal of pathological confirmed meningioma. ;Primary end point(s): - Discrimination between tumorous and non-tumorous tissue based on ex vivo Bevacizumab-IRDye800CW qualitative fluorescence measurements to determine the optimal dose of this tracer in intracranial meningioma. - Number of participants with adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) related to the use of Bevacizumab-IRDye800CW. ;Timepoint(s) of evaluation of this end point: After the first 9 patients, we will evaluate the safety profile and whether the tumor can be distinguished from background tissue based on qualitative fluorescence imaging ex vivo. We will select either the best group, or the two best groups of the dose escalation scheme, depending on the differences between the three cohorts at the moment of interim analysis. When a single group is selected, that cohort will be extended to 10 patients. When the two best groups are selected, these will first be expanded to six patients each, after which four patients will be additionally included in the best group. The final evalaution of results will be do | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Correlation of ex vivo fluorescent signal in meningioma and normal tissue with histopathology and immunohistochemistry. - Quantification of fluorescent signal by spectroscopy. - Ability to detect the in vivo (intra-operative) fluorescent signal in meningioma and normal tissue using the Zeiss Pentero with IR800 fluorescence module, and the Yoda. - Macroscopic quantification of the fluorescent signal of pathological confirmed meningioma. ;Timepoint(s) of evaluation of this end point: The timepoints for evaluation of the secondary endpoints are similar to the evaluation of the primary endpoints. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Neurosurgery
University Medical Center Groningen
Outcome results
None listed