跳至主要内容
临床试验/NCT07661706
NCT07661706招募中不适用

Data Collection of New Spectral CT Imaging Method

GE Healthcare1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
GE Healthcare
入组人数
50
试验地点
1
主要终点
Evaluable Raw Research Scans

研究概览

简要总结

The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.

详细描述

Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Who are ≥18 years of age;
  • Able to sign and date the informed consent form; AND,
  • Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.

排除标准

  • Who are pregnant or lactating;
  • Who were previously enrolled in this study;
  • For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;
  • For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
  • 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 or constitute a health hazard for the subject; OR,
  • Who are unwilling to have GEHC personnel present for the CT exam.

研究组 & 干预措施

Research CT

干预措施: Research CT (Device)

结局指标

主要结局

Evaluable Raw Research Scans

时间窗: Through study completion, an average of 1 year

Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)

次要结局

  • Safety Assessment(Through study completion, an average of 1 year)

研究者

发起方
GE Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验