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临床试验/NCT04560725
NCT04560725进行中(未招募)不适用

PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer

Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月22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
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
SUV

研究概览

简要总结

To study the radioactive uptake of [68Ga]P137 in the lesion sites of PCa patients and evaluate the ability of [68Ga]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).

详细描述

Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease.

[68Ga]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on [68Ga]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.

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

入选标准

  • Men over 18 years of age need to undergo [68Ga]P137 PET/CT examination for suspected prostate cancer.
  • The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.

排除标准

  • Significant hepatic or renal dysfunction;
  • Patients with malignant tumors other than prostate cancer within 2 years;
  • Ready to pregnant;
  • The patient can not tolerate all clinical tests.

研究组 & 干预措施

[68Ga] P137

Experimental

Imaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]P137 PET/CT scans.

干预措施: 11C-Choline (Drug)

结局指标

主要结局

SUV

时间窗: 2 years

The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)on PET/CT

次要结局

  • ROC(2 years)

研究者

发起方
Peking University Cancer Hospital & Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua Zhu

Associate Professor

Peking University Cancer Hospital & Institute

研究点 (1)

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