Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas
研究概览
简要总结
The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in patients with sporadic Vestibuarl Schwannomas.
详细描述
The radioligand 68Ga-NODAGA- E[c(RGDyK)]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/MR.
A total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-PET/MR scan. Follow-up MR-only scan will be performed (from the time of the angiogenesis PET/MR) minimum 2 months later in regards to calculate growth rate. The uptake of 68Ga-NODAGA-E[c(RGDyK)]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years with MRI verified sporadic vestibular schwannomas
- •Patients > 18 år whom max has been in watchful waiting regime in 12 months and/or max. received 1 follow-up MRI scan.
- •Must be able to read and understand the patient information in Danish and to give informed consent
排除标准
- •Pregnancy
- •Breast-feeding
- •Weight more than the maximum weight limit for the PET/MR bed of the scanner (140 kg)
- •History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2
- •Recent systemic treatment with steroids
- •Hormone treatment incl. birth control pills.
- •Claustrofobia
- •Non-MRI compatible implants.
研究组 & 干预措施
Angiogenesis PET/MR
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR
干预措施: One injection of 68Ga-NODAGA-E[c(RGDyK)]2 (Drug)
结局指标
主要结局
Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas
时间窗: 1 hour
The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used as a prognostic marker for growth rate in patients with sporadic vestibular schwannomas.
次要结局
未报告次要终点
研究者
Hjalte Sass
Principal Investigator
Rigshospitalet, Denmark