PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
2019年11月14日 更新者:University of Wisconsin, Madison
The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in human brain tumors.
This goal will be accomplished by quantifying tumor uptake and determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating tumor dosimetry.
The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
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
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital and Clinics
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants will have a contrast enhanced brain MRI which documents evidence of primary or metastatic brain tumor or suspected tumor recurrence after therapy
- Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
- Adult patients 18 or older
- Female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of 124I-NM404 Participants must not attempt to become pregnant during this time
- Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy
- Patient provides informed consent
- Karnofsky score ≥ 60
- For previously treated brain tumors, targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404
Exclusion Criteria:
- Life expectancy of < 3 months
- Allergy to potassium iodide (SSKI or Thyroshield)
- Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days
- Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at any time for 45 days after injection of 124I-NM404.
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:I124-NM404 brain metastases or GBM imaging
injection of I-124NM404 for imaging
|
injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404
injection of an experimental imaging agent, 5mCi I-124NM404
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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 |
---|---|---|
Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake
大体时间:24- and 48 hours post injection
|
TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value.
Imaging performed at 24- and 48 hours post injection.
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24- and 48 hours post injection
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Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors
大体时间:24- and 48 hours post injection
|
TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value.
Imaging performed at 24-, and 48 hours post injection.
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24- and 48 hours post injection
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Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake
大体时间:24- and 48 hours post injection
|
Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point.
Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses.
Imaging performed at 24- and 48 hours post injection.
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24- and 48 hours post injection
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Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors
大体时间:24- and 48 hours post injection
|
Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point.
Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses.
Imaging performed at 24-, and 48 hours post injection.
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24- and 48 hours post injection
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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:Lance Hall, MD、University of Wisconsin, Madison
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
2012年3月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2012年2月14日
首先提交符合 QC 标准的
2012年2月22日
首次发布 (估计)
2012年2月28日
研究记录更新
最后更新发布 (实际的)
2019年12月2日
上次提交的符合 QC 标准的更新
2019年11月14日
最后验证
2018年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RO11360
- A539300 (其他标识符:UW Madison)
- SMPH\RADIOLOGY\RADIOLOGY (其他标识符:UW Madison)
- 2011-0830 (其他标识符:Institutional Review Board)
- NCI-2012-02080 (注册表标识符:NCI Trial ID)
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.
NM404的临床试验
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University of Wisconsin, MadisonCellectar Biosciences, Inc.终止
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Cellectar Biosciences, Inc.完全的
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Universidad Autonoma de San Luis PotosíHospital Central "Dr. Ignacio Morones Prieto"完全的