68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
研究概览
简要总结
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.
详细描述
PRIMARY OBJECTIVES:
Evaluate the feasibility and biodistribution of 68Ga-PSMA.
OUTLINE:
Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.
After completion of study, patients are followed up at 24 hours and 1 week.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent
- •Known diagnosis of prostate cancer
- •Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
- •Able to remain still for duration of each imaging procedure (about one hour)
排除标准
- •Unable to provide informed consent
- •Inability to lie still for the entire imaging time
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
研究组 & 干预措施
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
干预措施: Computed Tomography (Procedure)
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
干预措施: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) (Drug)
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
时间窗: an estimated average of 1 hour
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.
Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
时间窗: an estimated average of 1 hour
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.
Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
时间窗: an estimated average of 1 hour
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
时间窗: an estimated average of 1 hour
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
次要结局
- Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan(an estimated average of 2 hours)
研究者
Andrei Iagaru
Associate Professor of Radiology
Stanford University