Clinical Application of Dual-target Imaging Agent [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
Preclinical studies have confirmed that [68Ga]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables [68Ga]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of [68Ga]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 18-85 years, expected survival ≥12 weeks.
- •Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
- •At least one measurable target lesion was present according to RECIST1.1 criteria.
- •Obtain written informed consent and be able to follow up
排除标准
- •Severe abnormal liver and kidney function
- •Fertile subjects will need to use effective contraception during the study
- •Unable to lie flat for half an hour
- •Refused to join this clinical investigator
- •Suffering from claustrophobia or other mental illness
- •Other conditions deemed unsuitable for participation in the trial
研究组 & 干预措施
P17-079+P15-041
干预措施: P17-079, P16-093, or P15-041 PET/CT (Diagnostic Test)
P17-079+P16-093
干预措施: P17-079, P16-093, or P15-041 PET/CT (Diagnostic Test)
结局指标
主要结局
SUV
时间窗: 0-180 min post-injection
measured by PET/CT
次要结局
未报告次要终点