跳至主要内容
临床试验/NCT03490812
NCT03490812进行中(未招募)不适用

Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2015年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
131
试验地点
2
主要终点
artifacts

研究概览

简要总结

The goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions.

详细描述

The prospective portion of study will utilize investigational PET acquisitions in addition to standard of care PET imaging to develop and optimize PET acquisition post-processing techniques as well as to generate preliminary and comparative data for potential clinical trials. These post-processing techniques include but are not limited to visual inspection of lesions, normal tissue, sentinel nodes and imaging artifacts, semi-quantitative analysis including the use of rating schemes, and using various published methods for image post-processing. The PET methodologies we plan to use as part of this study will allow us to obtain morphological, functional and molecular information. Patients receiving a standard of care PET will be asked by study personnel if they are interested in undergoing additional investigational acquisitions before or after their standard of care imaging. If the patient agrees, he/she will remain on the same PET scanner for up to an additional 30 minutes while more images are obtained. Each patient will be imaged for no longer than 2 hours (standard of care imaging and additional investigational imaging). A routine clinical report will be generated for the clinically indicated PET by a nuclear medicine physician. Once this routine clinical PET scan is dictated and finalized, a study team member will obtain the report via IHIS and manually remove all identifiers. This report is being obtained for comparative purposes. All the data being compared will be coded using a unique study number. The retrospective portion of this study will involve the review of pre-existing data from January 1, 2001 through December 5, 2017. The data to be reviewed/analyzed includes PET imaging data that has been previously collected in the course of standard clinical care. The PET imaging acquisitions obtained from the retrospective review will be utilized as a comparison to the investigational images obtained during the prospective portion of this study. The criteria that will be utilized to determine how the retrospective data will be utilized includes the following parameters: type of imaging study, diagnosis, age in decades, gender, and availability of data in the imaging archive.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female volunteers greater than or equal to 18 years of age
  • Patients receiving a standard of care PET scan at OSU

排除标准

  • Participants who are pregnant or lactating
  • Prisoners
  • Subjects incapable of giving informed written consent
  • Retrospective Population:
  • Inclusion Criteria:
  • Male and female patients greater than or equal to 18 years of age
  • Patients who have previously received a standard of care PET scan at OSU
  • Exclusion Criteria:

结局指标

主要结局

artifacts

时间窗: through study completion, on average 2-5 years

assessed by blinded readers

image quality

时间窗: through study completion, on average 2-5 years

assessed by blinded readers

lesion detectability

时间窗: through study completion, on average 2-5 years

assessed by blinded readers

image noise

时间窗: through study completion, on average 2-5 years

assessed region of interest over target tissue and background

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael V Knopp MD PhD

Professor

University of Cincinnati

研究点 (2)

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