NCT03334500进行中（未招募）早期 1 期
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
Men with a history of prostate cancer may be in this study. Subjects recommended for a prostatectomy or oligometastectomy will undergo PET/CT imaging using a novel radiotracer [18F]FTT to evaluate PARP-1 activity in known or suspected sites of primary or metastatic disease. Imaging will be compared with pathology results, including additional research assays when possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be ≥ 18 years of age
- •Biopsy proven prostate cancer
- •Must meet one of the following criteria:
- •At least two tissue cores containing at least 50% tumor (per pathology report) OR
- •At least one lesion that is 1 cm or greater in size by standard imaging (e.g. ultrasound, MRI, CT). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study.
- •Recommended for clinically indicated radical prostatectomy or oligometastectomy
- •Willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available)
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
排除标准
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Women, children, fetuses, neonates, or prisoners are not included in this research study.
研究组 & 干预措施
Cohort 1
Experimental
Gleason 6 (n=10)
干预措施: [18F]FluorThanatrace (Device)
Cohort 1
Experimental
Gleason 6 (n=10)
干预措施: Poly(ADP Ribose) Polymerase 1 (Drug)
Cohort 2
Experimental
Gleason 7-8 (n=10)
干预措施: [18F]FluorThanatrace (Device)
Cohort 2
Experimental
Gleason 7-8 (n=10)
干预措施: Poly(ADP Ribose) Polymerase 1 (Drug)
Cohort 3
Experimental
Gleason 9 or oligometastic disease (n=10)
干预措施: [18F]FluorThanatrace (Device)
Cohort 3
Experimental
Gleason 9 or oligometastic disease (n=10)
干预措施: Poly(ADP Ribose) Polymerase 1 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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