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临床试验/NCT03486886
NCT03486886已完成不适用

PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Metastasis detection yield

研究概览

简要总结

A promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa). This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan).

PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness.

[18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other modality for localization of the site of recurrence. Applications that show promise and require further investigation include the characterization and risk stratification of primary PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved identification of patients with oligometastatic disease.

The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort of patients at CHUM and establish the repeatability of the technique before investigating it more widely.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide informed consent
  • Metastatic prostate cancer.
  • At least 18 years of age
  • Standard imaging (bone scan, CT abdo/pelvis/chest) within 6 weeks of consent.

排除标准

  • 未提供

结局指标

主要结局

Metastasis detection yield

时间窗: 6 weeks

Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.

次要结局

  • Reproducibility of PSMA radiotracer uptake(2 weeks)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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