NCT05035732撤回不适用
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
研究概览
简要总结
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
详细描述
Primary Objective:
--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.
Secondary Objective:
--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
Exploratory Objective:
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients who are 18 years and older
- •Histologically or cytologically proven prostate carcinoma s/p definitive radiation
- •Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
- •Ability to understand and willingness to sign informed consent
排除标准
- •Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- •Patients with contraindication to undergo MRI
- •Patients with prior allergy to MRI contrast agent.
- •Extreme Claustrophobia
结局指标
主要结局
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
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