Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Gallium Ga 68-DOTATATE Uptake
研究概览
简要总结
This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.
详细描述
PRIMARY OBJECTIVE:
Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.
SECONDARY OBJECTIVE:
Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.
OUTLINE:
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
- •Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
- •Ability to lie still for PET scanning
- •Patients must be able to provide written informed consent
排除标准
- •Patients less than 18 years of age
- •Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
- •Inability to lie still for PET scanning
- •Patients unable to provide written informed consent
研究组 & 干预措施
Gallium Ga 68-DOTATATE PET/CT
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
干预措施: CT (Computed Tomography) (Procedure)
Gallium Ga 68-DOTATATE PET/CT
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
干预措施: Gallium Ga 68-DOTATATE (Drug)
Gallium Ga 68-DOTATATE PET/CT
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Gallium Ga 68-DOTATATE Uptake
时间窗: During PET/CT scan, up to 2 hours
The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.
次要结局
- Progression Free Survival(Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months)
研究者
Mehmet Bilen
Principal Investigator
Emory University