Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Standard uptake value(SUV)
研究概览
简要总结
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
详细描述
[68Ga]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged from 18 to 90 years old;
- •Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- •Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- •simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks;
- •Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
- •Sign informed consent.
排除标准
- •Patients who cannot cooperate with the examination;
- •Concurrent malignant tumors;
- •Previous alcohol allergy;
- •Patients with liver and kidney dysfunction;
- •Other circumstances deemed by the investigator to be inappropriate for trial participation.
研究组 & 干预措施
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11.
干预措施: [68Ga]Ga-PSMA-D5 (Drug)
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11.
干预措施: [68Ga]Ga-PSMA-11 (Drug)
结局指标
主要结局
Standard uptake value(SUV)
时间窗: 30 days
Standard uptake value(SUV) of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.
次要结局
- Number of lesions(30 days)
- Diagnostic efficacy(30 days)