PET-MR-PSA 前列腺癌复发研究 (PET-MR-PSA)
18F-Fluciclovine PET/MRI 检测根治性治疗后复发的前列腺癌
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Trondheim、挪威、7006
- St Olavs Hospital, PET center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
大体时间：10 years
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Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan. |
10 years
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合作者和调查者
调查人员
- 首席研究员：Tone F Bathen, PhD、The Norwegian University of Science and Technology (NTNU)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.