68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.
研究概览
简要总结
This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.
详细描述
68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.
A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent 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
68Ga-PSMA
Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.
干预措施: 68Ga-PSMA (Drug)
结局指标
主要结局
The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.
时间窗: 12 months
The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.
次要结局
- Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value(12 months)
研究者
Ebrahim Delpassand
Chairman and Medical Director
Radio Isotope Therapy of America