此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

2013年11月18日 更新者:David M. Schuster, MD

Anti-[18F]FACBC PET-CT for the Characterization of Primary Prostate Cancer

The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.

研究概览

地位

终止

条件

研究类型

介入性

注册 (实际的)

11

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Patients must be 18 years of age or older.
  • Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18
  • Inability to lie still for PET scanning
  • Cannot provide written informed consent.
  • Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:FACBC Imaging
Dynamic FACBC PET of primary prostate carcinoma.
Anti[18F]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis
大体时间:At 4, 16, 28 and 40 minutes post-injection of FACBC

Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.

Sensitivity: Proportion of people with a disease who have a positive test result

Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.

Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted

Accuracy: Ability of the test to differentiate between disease and non-disease.

Note: 'n=' is the denominator used to compute each parameter.

At 4, 16, 28 and 40 minutes post-injection of FACBC

次要结果测量

结果测量
措施说明
大体时间
Mean SUVmax of Low Versus High Gleason Groups
大体时间:4 minutes,16 minutes,28 minutes and 40 minutes
To determine id radiotracer uptake correlates with gleason score
4 minutes,16 minutes,28 minutes and 40 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:David M Schuster, MD、Emory University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2009年6月5日

首先提交符合 QC 标准的

2009年6月9日

首次发布 (估计)

2009年6月10日

研究记录更新

最后更新发布 (估计)

2014年1月7日

上次提交的符合 QC 标准的更新

2013年11月18日

最后验证

2013年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00008094
  • FACBC (其他标识符:Other)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅