Evaluation of Radiation Dose for [11C]Cimbi-36
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Effective dose and absorbed dose for selected organs
研究概览
简要总结
The purpose of this study is to determine the dosimetry for the Positron Emission Tomography (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11 labelling position.
详细描述
Healthy subjects wil undergo a whole-body Positron Emission Tomography (PET) scan with the Serotonin 2A Receptor (5-HT2A) radioligand [11C]Cimbi-36 or [11C]Cimbi-36-5 to determine the effective radiation dose and radiation dose for selected organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •18 years of age
- •Signed informed consent
排除标准
- •Present or former neurological disease, severe somatic or psychiatric disease, or medication thet can interfere with the test results.
- •Pregnancy at the time of the scan
- •Breastfeeding
- •Alcohol or substance abuse
- •Exposure to radiation (>10 millisievert (mSv)) within the last year, or significant exposure at work
- •Allergy to any of the substances in the Investigational medicinal product (IMP) formulation
研究组 & 干预措施
[11C]Cimbi-36
[11C]Cimbi-36
Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
干预措施: [11C]Cimbi-36 (Drug)
[11C]Cimbi-36-5
[11C]Cimbi-36-5
Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
干预措施: [11C]Cimbi-36-5 (Drug)
结局指标
主要结局
Effective dose and absorbed dose for selected organs
时间窗: 0 - 120 minutes
Based on the Positron Emission Tomography (PET) scan Time activity curves (TACs) will be generated and used for calculating the radiation doses for selected organs and over all effective radiation dose.
次要结局
- Measurement of radioactive metabolites in plasma(0 - 120 minutes)
- Measurement of radioactivity in plasma and whole blood(0 - 120 minutes)
研究者
Gitte Moos Knudsen
Chair, Professor, MD, DMSc
Rigshospitalet, Denmark