Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
研究概览
简要总结
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled PSMA-11 PET (Drug)
结局指标
主要结局
True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
时间窗: 1 day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
时间窗: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
时间窗: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
时间窗: 1 Day
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
次要结局
- Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.(1 Day)
- True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only(1 Day)
- True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only(1 Day)
- PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only(1 Day)
- PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT)(1 Day)
- PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only(1 Day)
- PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only(1 Day)
- Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment(1 Day)
- Percent of Participants With a Change in Clinical Management(Up to 6 months)
- Rate of Inter-reader Reproducibility for Positivity(1 Day)
- Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events(Up to 30 days)
研究者
Thomas Hope
Assistant Professor
University of California, San Francisco