18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
研究概览
简要总结
Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.
详细描述
The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA > 0.2 ng/ml following radical prostatectomy or PSA > 2.0 ng/ml above the nadir following definitive radiotherapy)
- •potential candidates for salvage treatment based on age and co-morbidity.
排除标准
- •general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
- •impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
结局指标
主要结局
Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
时间窗: 10 years
Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.
次要结局
未报告次要终点