FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer
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
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:FACBC Imaging
Dynamic FACBC PET of primary prostate carcinoma.
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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.
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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 |
|---|---|---|
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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
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean SUVmax of Low Versus High Gleason Groups
大体时间:4 minutes,16 minutes,28 minutes and 40 minutes
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To determine id radiotracer uptake correlates with gleason score
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4 minutes,16 minutes,28 minutes and 40 minutes
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合作者和调查者
调查人员
- 首席研究员:David M Schuster, MD、Emory University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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