Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- SUVmax on 18F-DCFPyL PET/CT
研究概览
简要总结
Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.
The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Resident of Canada
- •Age 18 years or older
- •Previous diagnosis of prostate cancer with Gleason Score available
- •ECOG performance status 0 - 3, inclusive
- •Able to understand and provide written informed consent
- •Under referring physician's care
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation
排除标准
- •Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
- •Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
- •Patients with unmanageable claustrophobia
研究组 & 干预措施
18F-DCFPyL PET/CT
18F-DCFPyL PET/CT Scan
干预措施: 18F-DCFPyL PET/CT (Drug)
结局指标
主要结局
SUVmax on 18F-DCFPyL PET/CT
时间窗: 24 hours
Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer
次要结局
未报告次要终点
研究者
Stephan Probst
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital