The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer
研究概览
简要总结
micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.
详细描述
- Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
- Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
- Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
- Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
- Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.
排除标准
- •Patients who did not meet the requirements as assessed by the investigator.
研究组 & 干预措施
18F-PSMA-1007
Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer.
Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition.
PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions.
干预措施: 18F-PSMA-1007 (Drug)
18F-FDG
The corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer
时间窗: 1 day
For patients receiving 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT imaging was performed, and image visual analysis, semi-quantitative analysis and prognostic study were performed on PET/CT images. To evaluate the diagnosis, staging and prognosis of 18F-PSMA-1007
次要结局
未报告次要终点
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University