[18F]mFBG PET-CT imaging of pheochromocytoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The number of detected pheochromocytoma lesions, proved by histology, with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue, compared to number of lesions detected on protocollary conventional CT imaging prior to surgery.
研究概览
简要总结
The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG PET-CT compared to the conventional CT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The patient has provided written informed consent authorization before participating in the study. - The patient is ≥18 years of age at the time of consent. - The patient has a diagnosis of pheochromocytoma with a known anatomical location or laboratory findings suspicious for pheochromocytoma defined as elevated serum/plasma metanefrines. - The patient should have surgery planned. - The patient should have had a CT scan not older than 8 weeks at time of the [18F]mFBG PET-CT.. - The patient has an ECOG status of Grade 0 – 2.
排除标准
- •Patient is mentally or legally incapacitated. - Patient is pregnant or lactating. - Patient has active serious infections not controlled by antibiotics. - Patient is unable or unwilling to undergo PET-CT scanning or surgery. - Patient did receive interfering treatment between conventional CT scanning and [18F]mFBG PET-CT.
结局指标
主要结局
The number of detected pheochromocytoma lesions, proved by histology, with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue, compared to number of lesions detected on protocollary conventional CT imaging prior to surgery.
The number of detected pheochromocytoma lesions, proved by histology, with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue, compared to number of lesions detected on protocollary conventional CT imaging prior to surgery.
次要结局
- 1)Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values at 1 and 2 hours on PET-CT imaging. 2) Correlation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. 3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging 4) Safety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes
研究者
Dr. B. de Keizer
Scientific
Universitair Medisch Centrum Utrecht