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89Zr-Bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic neurofibromatosis type 2.

Phase 1
Conditions
eurofibromatosis type 2
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2020-000156-35-NL
Lead Sponsor
eiden University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
15
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Patients aged 18 years or older
-Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C)
-Provided written informed consent
-Patients must have measurable disease, defined as at least one VS > 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced T1-weighted cranial MRI scan.
-Eligible and planned for bevacizumab treatment
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements.
-Patients with a known allergy to substances used in this study

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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