2024-512860-75-00尚未招募2 期
(NFPET) ‘89Zr-Bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic neurofibromatosis type 2
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The correlation of the results of the pre-treatment 89Zr- Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy.
研究概览
简要总结
To validate pre-treatment [89Zr]-bevacizumab PET/CT as an imaging biomarker for prediction of a hearing response to bevacizumab treatment in patients with NF2 related (vestibular) schwannomas.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Concurrent treatment with Everolimus
结局指标
主要结局
The correlation of the results of the pre-treatment 89Zr- Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy.
The correlation of the results of the pre-treatment 89Zr- Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy.
次要结局
- Correlations of pre-treatment 89Zr-Bevacizumab PET/CT imaging with patient-reported outcome measures (PROM), vestibular function, cranial nerve (dys)function, kidney function and nontarget schwannoma response after bevacizumab treatment in NF2-patients.
研究者
Prof.dr. A.J. Gelderblom
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
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