跳至主要内容
临床试验/NCT05940259
NCT05940259招募中不适用

A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate

研究概览

简要总结

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

[68Ga]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

详细描述

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.[68Ga]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

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 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients with confirmed or suspected cancer; Signed written informed consent

排除标准

  • 未提供

研究组 & 干预措施

[68Ga]P3

Experimental

Subjects with suspected or confirmed Prostate will receive an intravenous injection of 68Ga-P3 followed by PET imaging.

干预措施: [68Ga]P3 (Drug)

结局指标

主要结局

The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate

时间窗: 1 year

the standardized Uptake Value (SUV) of lesions on 68Ga-P3 PET/CT

The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate

时间窗: 1 year

the number of lesions detected by 68Ga-P3 PET/CT, based on the pathology or clinical follow-up as gold standard.

次要结局

  • Correlation with pathological expression(1 year)
  • The dosimetry of 68Ga-P3(1 year)
  • Quantitative evaluation of 68Ga-P3(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xing YANG

Principal Investigator

Peking University First Hospital

研究点 (1)

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