Biodistribution and Mechanism of Action of the 11C-labeled PET Tracer Sarcosine in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics and Biodistribution in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
研究概览
简要总结
Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.
详细描述
Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 40 years of age or older
- •Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)
排除标准
- •Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
- •Body weight > 350 lbs (158 kg)
- •Prisoners
- •Subject not willing or able to sign informed consent
研究组 & 干预措施
Prostate Cancer
Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.
干预措施: 11C-sarcosine (Drug)
Prostate Cancer
Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.
干预措施: 11C-choline (Drug)
Healthy Volunteer
Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes.
干预措施: 11C-sarcosine (Drug)
结局指标
主要结局
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
时间窗: One Month
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
时间窗: One Month
次要结局
- Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials(One Month)
- Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline(One Month)
- Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures(One Month)
研究者
Morand Piert, MD
Principal Investigator
University of Michigan