Positron Emission Tomography/Computed Tomography (PECT/CT) Double-Scanning Study
Evaluation of Advancements in PET/CT Imaging
This study aims to collect clinical image data using the Omni 128 cm PET/CT system and compare image quality and performance with clinically indicated PET/CT examinations. Adult participants undergoing a clinically indicated PET/CT scan will also undergo imaging on the Omni 128 cm PET/CT system for research evaluation purposes.
研究概览
详细说明
This study is evaluating a new PET/CT imaging system, Omni 128 cm PET/CT. Adults undergoing a clinically indicated PET/CT scan will also receive an additional research scan on the Omni system. Researchers will compare the images and collect imaging data to help assess the performance of the new technology. The information gathered may be used to support regulatory submissions, improve future PET/CT systems, and advance medical imaging research. Participation involves a single study visit and no follow-up is required.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Erin Terrell, MS
- 电话号码：262-449-3363
- 邮箱：erin.terrell@gehealthcare.com
学习地点
-
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California
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Stanford、California、美国、94305
- 招聘中
- Stanford University
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首席研究员：
- Andrei Iagaru, MD
-
接触：
- Andrea Otte, DPT, CCRC
- 电话号码：650-736-4183
- 邮箱：anotte@stanford.edu
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副研究员：
- Erin Grady, MD
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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
Participants who have a clinically indicated PET/CT examination according to current clinical practice standards and according to the data required for the study will be enrolled in this study.
描述
Inclusion Criteria:
- Must have a clinical indicated PET/CT exam scheduled including (but not limited to) one of the following radiopharmaceutical tracers: Fluorodeoxyglucose (FDG or 18F-FDG), 18F-DCFPyL; 68Ga- PSMA; 68Ga Dotatate; 18F Amyloid (18F- Florbetapir, 18F-Florbetaben, or 18F-Flutemetamol), or Other standard PET tracers;
- Age ≥ 18 years old at time of consent;
- Able to provide informed consent; AND,
- Has the necessary mental capacity to understand instructions and is able to comply with protocol requirements.
Exclusion Criteria:
- Who, per the site's SOPs, has any condition that would prevent the clinically indicated PET/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, elevated blood glucose, etc.);
- Who were previously enrolled in this study;
- Who need urgent or emergent care;
- Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results, constitute a health hazard for the subject;
- Unwilling to have GEHC personnel present during scans; OR,
- Unable to tolerate the exam.
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Single Group Study
Adult patients scheduled to undergo a clinically indicated PET/CT |
Participants will undergo two PET/CT scans. The first scan will be performed on a commercially available PET/CT system as part of standard clinical care, and the second scan will be performed on the investigational Omni 128 cm PET/CT system. The investigational scan will begin within one hour of completion of the standard-of-care scan. No additional radiopharmaceutical tracer will be administered before the second imaging session. |
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 |
|---|---|---|
|
Number of Complete PET/CT Device Data Sets Collected
大体时间：Through study completion, an average of 6 months
|
The primary outcome is the number of complete and evaluable PET/CT imaging datasets successfully collected from both the standard-of-care PET/CT scan and the investigational Omni 128 cm PET/CT scan. Device data may include PET raw scan data, PET list-mode data, PET DICOM images, and CT DICOM images. The collected data will be used to evaluate system performance and support future technology development, scientific assessment, and regulatory submissions. |
Through study completion, an average of 6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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
其他相关的 MeSH 术语
其他研究编号
- SA-000165
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.