89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hearing response (HR) - PTA
研究概览
简要总结
Bevacizumab can be an effective treatment for individuals with NF2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of NF2 patients. However, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden.
Therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. Patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Per standard-of-care bevacizumab therapy is administered every three weeks for six months. To monitor treatment effect, follow-up is performed at 3-month intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
- •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
研究组 & 干预措施
Bevacizumab
After determining eligibility, all patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Patients will first receive 5 mg 89Zr-Bevacizumab 4 days before PET/CT scan. This is followed by standard-of-care intravenous 7.5mg/kg bevacizumab (Avastin) therapy, administered every three weeks for six months
干预措施: Bevacizumab Zirconium Zr-89 (Drug)
结局指标
主要结局
Hearing response (HR) - PTA
时间窗: 6 months
Pure Tone Average (PTA), in dB
Hearing response (HR) - WRS
时间窗: 6 months
Word Recognition Score (WRS), % at x dB
Radiographic response (RR) - ADC
时间窗: 6 months
Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter
Radiographic response (RR) - tumor volumetry on MRI
时间窗: 6 months
Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm
Radiographic response (RR) - Microbleeds
时间窗: 6 months
Location and number of microbleeds
Radiographic response (RR) - Diffusion restriction
时间窗: 6 months
Diffusion restriction, yes / no
次要结局
- Patient reported outcome measures (PROM)(6 months)
- Physical examination(6 months)
- Vestibular Function(6 months)
- Renal function(6 months)
研究者
Hans Gelderblom
Prof. A.J. Gelderblom, MD, PhD, Head of Medical Oncology, Principal Investigator
Leiden University Medical Center