EUCTR2014-005073-37-DK进行中（未招募）1 期
68Ga-PSMA PET/CT for detection of recurrent prostate cancer: Comparison with 18F-fluoride PET/CT, MRI and DW-MRI
Department of Nuclear Medicine, Aalborg University Hospital0 个研究点开始时间: 2014年12月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •A subject is eligible for the study if all of the following apply:
- •Oral and written informed consent.
- •18 years and older.
- •The patient has undergone a curatively intended treatment for prostate cancer, which is considered to be radical at the end of the intervention/procedure.
- •Confirmed PCa recurrence (defined as PSA = 0.2 ng/ml or more after radical prostatectomy or a rise of 2.0 ng/ml above the post-treatment PSA-nadir following radiation therapy).
- •Subject is able to lie still for the duration of the imaging procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer and prostate cancer.
- •History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer.
- •Subjects unable to undergo the PET/CT imaging procedure due to claustrophobia despite oral anxiolytics (institutional procedure).
- •Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry.
- •Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
- •If the patient refuses MRI or is not eligible (e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.
研究者
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