Spectral Analysis Probe to Identify Glioblastoma Cells
2019年1月24日 更新者：University of Oklahoma
Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection
This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.
研究概览
地位
终止
条件
详细说明
This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical resection.
Eligible patients who have consented to the use of the Chaos Wand will be scheduled for surgery as standard cancer care for GBM.
During the surgical procedure, the Chaos Wand Spectral Diagnosis Probe will be utilized.
Fifteen intraoperative readings and signal recordings of GBM tissue will be taken.
The wand will only be used in areas that have already been deemed in need of resection due to GBM disease.
Each site identified for spectral analysis will be marked.
The wand does not come into contact with the brain at any point during this procedure.
Following surgical resection of the GBM tumor, tissue will be collected from the same 15 sites where the Chaos Wand was used.
The pathology report will be compared with the results of spectral analysis.
研究类型
观察性的
注册 (实际的)
12
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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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma Health Sciences Center
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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
取样方法
非概率样本
研究人群
The study population includes adult patients from the outpatient neurosurgery clinic or those who have presented through the University of Oklahoma emergency department and have been diagnosed with glioblastoma or are suspected of having glioblastoma based on pre-operative imaging.
The Stephenson Cancer Center will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status.
Every attempt will be made to enter all eligible patients into this protocol and therefore address the study objectives in a patient population representative of the entire patient population with GBM.
描述
Inclusion Criteria:
- Male or Female and over 18 years of age.
- Patients with histologically proven GBM who are newly diagnosed and eligible to undergo surgical treatment or patients who are suspected of having glioblastoma on pre-operative imaging which is subsequently confirmed by histopathology following tumor resection.
- Patients must be able to understand and willing to sign the informed consent document.
Exclusion Criteria:
- Patients with absence of glioblastoma.
- Patients who are not undergoing tumor resection.
- Patients who have prior brain radiotherapy
- Patients who have prior systemic chemotherapy
- Patients who are not willing to sign the informed consent and agree to participate.
- Patients who are pregnant or nursing
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
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 |
|---|---|---|
|
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
大体时间：6 months
|
For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma.
For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%.
A mean value with standard deviation will be reported across all participants in the study.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
大体时间：Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.
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Up to 1 month following surgery
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Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery
大体时间：Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.
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Up to 1 month following surgery
|
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Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery
大体时间：Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.
|
Up to 1 month following surgery
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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：Michael Sughrue, MD、University of Oklahoma
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 (实际的)
2017年10月31日
初级完成 (实际的)
2018年9月30日
研究完成 (实际的)
2018年9月30日
研究注册日期
首次提交
2017年9月12日
首先提交符合 QC 标准的
2017年9月25日
首次发布 (实际的)
2017年9月26日
研究记录更新
最后更新发布 (实际的)
2019年1月25日
上次提交的符合 QC 标准的更新
2019年1月24日
最后验证
2019年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 8285
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.