The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
研究概览
简要总结
The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
详细描述
Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and localize prostate cancer in humans in vivo. There is extensive data in the literature showing the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer. The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a diagnostic and decision making tool in the management prostate cancer patients. During the study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
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
- •Previously diagnosed with prostate cancer, under referring physician's care
- •ECOG performance status 0 - 3, inclusive
- •Able to understand and provide written informed consent
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation
排除标准
- •Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- •Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- •Patients with unmanageable claustrophobia
- •Clinical Indication Criteria Subgroups:
- •BCR: Biochemical recurrence as defined by serum PSA > 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management
- •HRS: Staging of high risk patients as defined by any one of the following:
- •Gleason score > 7
- •Serum PSA > 10 ng/ml
- •T stage of T3 or greater on TNM staging
- •Equivocal conventional staging such as CT, MRI or bone scan
- •Clinical suspicion of advance stage disease (e.g. bone pain)
研究组 & 干预措施
68Ga-PSMA PET/CT
68Ga-HBED-CC-PSMA PET/CT
干预措施: 68Ga-HBED-CC-PSMA PET/CT (Drug)
结局指标
主要结局
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
时间窗: 12 months
Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)
时间窗: 7 days
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
时间窗: 12 months
次要结局
未报告次要终点
研究者
Stephan Probst, MD
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital