Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System
Feasibility Study for Detection of Cervical Lymph Node Metastases With a High-Resolution PET Imaging System in Patients With Known or Suspected Cancers of the Upper Aerodigestive Tract
The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT.
Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.
研究概览
地位
条件
详细说明
If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.
You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of the part of the neck that has, or is suspected to have cancer. It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.
Length of Study:
After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.
This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast. Using the PEMFlex Solo II for imaging any other parts of the body is investigational.
Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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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
取样方法
研究人群
描述
Inclusion Criteria:
- A signed informed consent.
- Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET.
- Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.
- Scheduled for routine clinical imaging at the ACB PET/CT facility.
- Participant must be at least 18 years of age.
Exclusion Criteria:
- Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.
- Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.
- Uncontrolled blood glucose levels (>200 mg/dl).
- Patient is unable to comprehend the requirements of the study.
- Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.
大体时间：20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging
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20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging
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合作者和调查者
调查人员
- 学习椅：Eric Rohren, MD、M.D. Anderson Cancer Center
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
与本研究相关的术语
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.