Correlation Between SUV on 68Ga-HBED-CC-PSMA 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
- 88
- 试验地点
- 1
- 主要终点
- SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer
研究概览
简要总结
Prostate cancer is the second leading cause of cancer death in North American men older than 50 years. 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. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a tracer for prostate cancer PET imaging. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.
Study Objectives:
The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA 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.
This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will be performed on study participants. A PET/CT scan takes 2-3 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Referred by a treating physician
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug
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 who are claustrophobic
研究组 & 干预措施
68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT
干预措施: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT (Drug)
结局指标
主要结局
SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer
时间窗: Through study completion, one day
次要结局
未报告次要终点
研究者
Stephan Probst
MD
Sir Mortimer B. Davis - Jewish General Hospital
