Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
研究概览
简要总结
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Biochemical recurrent prostate cancer
IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for ~ 60 min (~150 min for first 10 patients/dosimetry) starting immediately after injection.
A contrast CT scan follows PET scan.
干预措施: Ga-68 P16-093 PET/CT scan (Drug)
Intermediate/High Risk primary prostate cancer
IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for ~ 50 min.
干预措施: Ga-68 P16-093 PET/CT scan (Drug)
结局指标
主要结局
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
时间窗: 2-60 days following PET/CT scan
We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from \~ 5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames.
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
时间窗: 4 months
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Sensitivity of Ga-68-P16-093 in BCR
时间窗: 2 weeks
We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.
次要结局
未报告次要终点