Exendin PET/CT for imaging of paragangliomas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Detection rate of PGLs (paragangliomas) using 68Ga-exendin-4 PET/CT
研究概览
简要总结
The main study aim of the study is to examine the feasibility of detecting PGLs using 68Ga-exendin-4 PET/CT.
详细描述
Rationale:
Functional imaging of paragangliomas (PGLs) is not unequivocal. Existing functional imaging modalities show good but variable results in PGLs, warranting the search for additional molecular imaging targets. Investigators aim to evaluate the glucagon-like peptide 1 receptor (GLP-1R) as a novel target for molecular imaging of PGLs. For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomography/computed tomography (PET/CT) imaging.
Objective:
The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localization and functional characterization of PGLs.
Study design:
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 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Proven sympathetic PGL with a single tumor detected using standard diagnostic imaging
- •No evidence of metastatic disease
- •CT and SSTR PET/CT performed (golden standard diagnostic imaging)
- •Scheduled for surgery
- •Able to sign informed consent
排除标准
- •Breast feeding
- •Pregnancy or the wish to become pregnant within 1 month
- •Calculated creatinine clearance below 40ml/min
- •Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)
- •Age < 18 years
- •Not able to sign informed consent
结局指标
主要结局
Detection rate of PGLs (paragangliomas) using 68Ga-exendin-4 PET/CT
Detection rate of PGLs (paragangliomas) using 68Ga-exendin-4 PET/CT
次要结局
- optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
- Comparison of quantitative imaging paramters (SUV, tumor-to-background ratio, contract-to-noise ratio) between Optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT, 18F-FDG PET and SSTR PET
- correlation between GLP-1R expression and tracer uptake in the PGLs
- Correlation quantitative imaging results and IHC data to the genetic origin of the PGLs
研究者
Sevilay Tokgöz
Scientific
Stichting Radboud universitair medisch centrum