跳至主要内容
临床试验/NCT03438123
NCT03438123
已完成
不适用

A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera

Spectrum Dynamics1 个研究点 分布在 1 个国家目标入组 140 人2017年11月28日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Dementia
发起方
Spectrum Dynamics
入组人数
140
试验地点
1
主要终点
CZT SPECT Image Acquisition
状态
已完成
最后更新
6年前

概览

简要总结

This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.

详细描述

The Spectrum Dynamics Multi-purpose CZT SPECT camera is a whole body SPECT (single photon emission computed tomography) scanner which utilises solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body. The CZT SPECT camera detects the location and distribution of gamma-emitting radionuclides in the body and produces 3 dimensional cross-sectional images through computed reconstruction of the data for the purpose of determining various metabolic and physiologic functions in the human body. In comparison to conventional sodium iodide (NaI) gamma camera (or Anger camera) technology, solid state CZT technology offers improved energy, spatial and temporal resolution, and higher count rates. Improvements in energy resolution and sensitivity thus enable the potential capability for enhanced quantification, simultaneous dual isotope imaging and dynamic imaging acquisition. The camera system also incorporates a multi-slice CT gantry and acquired SPECT and CT images can be combined to improve image reconstruction by allowing fusion of CT and SPECT image data for anatomic localisation referencing and CT attenuation correction of the SPECT image data.

注册库
clinicaltrials.gov
开始日期
2017年11月28日
结束日期
2019年10月15日
最后更新
6年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Spectrum Dynamics
责任方
Sponsor

入排标准

入选标准

  • Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission
  • Patient is aged ≥18 years
  • Patient condition is stable
  • Patient is willing and able to undergo image acquisition on the MPC CZT SPECT camera with integrated CT in addition to standard clinical scintigraphy procedure
  • Patient must be willing and able to provide written informed consent
  • Patient must be affiliated to a social security scheme

排除标准

  • Patient with unstable medical condition
  • Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
  • Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred

结局指标

主要结局

CZT SPECT Image Acquisition

时间窗: 1 day

Technical adequacy of acquired CZT SPECT images for demonstrating the location and distribution of gamma ray radionuclides within the body

CZT SPECT-CT Image Acquisition

时间窗: 1 day

Technical adequacy of acquired CZT SPECT-CT images for demonstrating the location and distribution of gamma ray radionuclides within the body

次要结局

  • Comparative Quality of CZT and Anger SPECT Images(1 day)
  • CZT SPECT Image Quality(1 day)
  • Safety of the CZT SPECT Camera(Through study completion; anticipated to be 24 months)
  • CZT SPECT-CT Image Quality(1 day)
  • Comparative Quality of CZT SPECT-CT and Anger SPECT Images(1 day)
  • Safety of the CZT SPECT Camera During Imaging Procedures(1 day)
  • Safety of the CZT SPECT-CT Camera(Through study completion; anticipated to be 24 months)
  • Safety of the CZT SPECT-CT Camera During Imaging Procedures(1 day)

研究点 (1)

Loading locations...

相似试验