跳至主要内容
临床试验/NCT04693169
NCT04693169进行中(未招募)不适用

[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients

Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月15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
20
试验地点
1
主要终点
SUV(standardized uptake value)

研究概览

简要总结

To investigate the radioactive uptake of [Al 18 F]PSMA137 in PCa patients, and evaluate the ability of [Al 18 F]PSMA137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).To provide an approach for screening patients high expression of PSMA, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.

详细描述

Prostate cancer (PCa) is the most common malignant tumor in the male reproductive system, and its prognosis and treatment mainly depend on the discovery of the primary disease and the early stage of metastasis, while traditional imaging and histological methods are difficult to meet the clinical requirements for the early diagnosis and accurate staging of PCa.Positron emission tomography (PET) has the characteristics of precision and non-invasive, so the development of PCa targeted molecular probe is of great significance for improving the specificity and accuracy of PCa diagnosis.

PSMA is a highly specific prostatic epithelial 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.

The radionuclides used for PET imaging include 18F (T 1/2 =109.8min), which has a suitable half-life and cyclotron preparation to enable the high yield synthesis of 18F labeled tracer, so it can be used in more patients and provided to other departments without on-site tracer production facilities.In addition, coordination labeling method is simple, easy to realize automatic synthesis technology and medicine box preparation.Therefore, 18F-labeled PSMA targeted molecular probe is a hot spot in the diagnosis of prostate cancer.

[Al18F]PSMA137 is a novel PSMA targeted tracer labeled with 18F. NOTA is used as a bifunctional chelating agent to facilitate better chelation with Al18F. It has a higher tumor uptake and a faster metabolism in normal organs with a lower background.[Al18F]PSMA137, as a novel targeted molecular probe, shows excellent properties in tumor cell uptake.This project provides research on [Al18F]PSMA137 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 [Al18F]PSMA137 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

[Al18F]PSMA137 PET/CT imaging

Experimental

All study participants will be allocated to this arm (single-arm study).Study participants will undergo [Al18F]PSMA137 PET/CT scans.

干预措施: 11C-Choline (Drug)

结局指标

主要结局

SUV(standardized uptake value)

时间窗: 2 years

SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer (\[Al18F\]PSMA137) in the primary and metastatic tumor lesions by measuring SUV on PET/CT

次要结局

未报告次要终点

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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