Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls.
研究概览
简要总结
Purpose of this clinical phase 1 trial was to determine if para-chloro-2-[18F]fluoroethyletomidate positron emission computed tomography ([18F]CETO-positron emission computed tomography(PET)/computed tomography(CT)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable?
详细描述
After receiving oral and written information about the study and its potential risks, all participants provided written informed consent. All participants underwent a screening visit 1-28 days before their [18F]CETO PET/CT. At the screening visit their medical history was obtained, including besides information of previous disease(s) and medication, also a clinical examination, WHO performance status, height, weight, pulse rate and blood pressure, blood chemistry and haematology.
Right before the PET/CT investigation a baseline assessment was performed including:
- A physical examination according to Modified Early Warning Score (MEWS)
- 12-lead electrocardiogram (ECG)
- Any concomitant medications was recorded
- Medical history - occurrence of any new symptoms and events since the screening visit
- Hematology (International Normalized Ratio (INR) in patients with antiocoagulant treatment).
- Pregnancy test in women.
- Assessment of injection site monitored by visual inspection (rash and phlebitis)
Participants received on average 0,76 mikrograms (range 0,1-1.37 mikrograms) of administered mass of CETO in conjunction to the PET/CT investigation.
Potential adverse events were monitored closely during, and after the administration of [18F]CETO, with access to emergency medicine resources.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma
- •For healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies.
- •Exclusion Criteria for patients and healthy volunteers:
- •pregnancy, age below 18, claustrophobia
排除标准
- 未提供
研究组 & 干预措施
First-in-man investigastion of [18F]CETO
15 patients were investigated with PET/CT after injection of 2,5 MBq/kg [18F]CETO. 5 healthy volunteers were investigated twice (Test-retest), with approximately 2 weeks in-between each PET/CT investigation, after injection of 1,3 MBq/kg [18F]CETO. Arterial blood samples were taken as well as urinary sampels.
3 out of 5 healthy volunteers were also investigated twice with PET/CT after injection of 13,2 MBq/kg [15O]water, performed before the [18F]CETO PET/CT.
干预措施: F18CETO (Drug)
结局指标
主要结局
Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls.
时间窗: Up to 1 day after the [18F]CETO PET/CT for each patient
Number of patients with treatment-related adverse events as assessed by clinical Adverse Events and Common ToxicityNCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
次要结局
- Evaluate [18F]CETO as a PET- biomarker for the adrenals and to diagnose and visualize primary aldosteronism, cortisol producing adrenocortical adenoma and non-functioning adrenocortical adenoma in up to 15 patients(Up to 24 month)
- Biodistribution of [18F]CETO(Up to 22 month)
- Compare uptake of [18F]CETO in normal adrenal glands in patients comparing healthy controls and determine the test - retest variability of [18F]CETO.(Up to 24 month)