跳至主要内容
临床试验/NCT02796807
NCT02796807已完成2 期

Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer

Sir Mortimer B. Davis - Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Sir Mortimer B. Davis - Jewish General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Probst

MD

Sir Mortimer B. Davis - Jewish General Hospital

研究点 (1)

Loading locations...

相似试验