Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of Fluorocholine PET/CT
研究概览
简要总结
This is a single-arm, open-label, phase III trial in up to 2000 patients with known or suspected benign or malignant tumors which are known or suspected to be 18F-fluorocholine-avid.
Patients will receive regular standard clinical care. The only study-specific procedure will be the administration of 18F-fluorocholine followed by a PET/CT scan.
Diagnostic accuracy of 18F-fluorocholine PET/CT will be captured versus a composite clinical, radiological and histopathological standard of truth at follow-up.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Under referring physician's care
- •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 30 minutes and tolerating intravenous cannulation for injection
- •Known or suspected benign or malignant tumor which is known or suspected to be 18F-fluorocholine-avid as per current medical literature
排除标准
- •Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- •Exceeding the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- •Unmanageable claustrophobia
研究组 & 干预措施
Fluorocholine PET/CT
The sole study-specific procedure is a single 18F-fluorocholine positron emission tomography / computed tomography (PET/CT). Subjects will receive 9 mCi 18F-fluorocholine IV, 5 to 120 minutes prior to PET/CT. 18F-fluorocholine PET/CT studies will be performed on hybrid PET/CT scanners which combine a dedicated, full-ring PET scanner with a multi-slice spiral CT scanner.
干预措施: 18F-fluorocholine PET/CT. (Drug)
结局指标
主要结局
Diagnostic accuracy of Fluorocholine PET/CT
时间窗: 1 day
Sensitivity, specificity, positive predictive and negative predictive values of 18F-fluorocholine PET/CT in the detection of tumor lesions as compared to a composite truth standard.
次要结局
- Incidence of treatment-emergent adverse events following Fluorocholine PET/CT(30 minutes)
研究者
Stephan Probst, MD
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital