Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer - an Interscan Variability and Intraobserver Agreement Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
研究概览
简要总结
In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.
详细描述
The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.
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
- 否
入选标准
- •Willing and able to provide written informed consent
- •History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- •Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.
- •Prior docetaxel-based chemotherapy is permitted
- •Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
排除标准
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- •Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
- •Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
- •Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
- •Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
研究组 & 干预措施
18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
干预措施: 18F-DCFPyL Injection (Drug)
结局指标
主要结局
Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
时间窗: 3 years
The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.
Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline
时间窗: Change from baseline to up to 4 weeks
Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.
次要结局
未报告次要终点