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临床试验/NCT03650946
NCT03650946Unknown不适用

Clinical Application of 68Ga-PSMA PET in Prostate Cancer

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

详细描述

Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Histologically confirmed prostate cancer

排除标准

  • Patients with known malignancy in other organs.
  • Patients with severe claustrophobia or unstable vital sigh
  • Other serious comorbidities evaluated by primary investigator

结局指标

主要结局

Diagnostic accuracy

时间窗: 1 year

initial staging compared to pathology, clinical and follow-up result

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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