Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of cancers diagnosed
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography, may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose F 18 positron emission tomography in finding cancer.
PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.
详细描述
OBJECTIVES:
Primary
- Demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of PET-CT with 18-FDG in patients with idiopathic venous thromboembolism.
Secondary
- Assess the risk of cancer detected at 1 year.
- Assess whether PET allows earlier detection of cancer.
- Evaluate survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of idiopathic venous thromboembolism (IVTE) meeting 1 of the following criteria:
- •Newly diagnosed
- •Recurrent disease controlled by anticoagulant therapy
- •No IVTE caused by a reversible major risk factor
- •No IVTE caused by a major constitutional risk factor, including any of the following:
- •Antiphospholipid antibody syndrome
- •Antithrombin deficit
- •Protein C
- •Protein S
- •PATIENT CHARACTERISTICS:
- •Not pregnant
- •No other known active cancer at the onset of IVTE
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
干预措施: fludeoxyglucose F 18 (Radiation)
Arm II
Patients only undergo standard diagnostic methods.
干预措施: diagnostic procedure (Procedure)
结局指标
主要结局
Number of cancers diagnosed
时间窗: 24 months
次要结局
未报告次要终点