A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
研究概览
简要总结
Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Be ≥ 18 years of age
- •Diagnosed with prostate cancer
- •Be willing and able to provide informed consent
- •Be informed of the investigational nature of this study
排除标准
- •Having a history of severe claustrophobia
- •Weight exceeding 400lbs
研究组 & 干预措施
Routine F-18 fluciclovine-PET/CT scan
This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy.
Research F-18 fluciclovine-PET/CT scan
This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy.
干预措施: F-18 fluciclovine-PET/CT scan (Diagnostic Test)
结局指标
主要结局
True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
时间窗: 1 year
True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy
次要结局
未报告次要终点