跳至主要内容
临床试验/NCT05592444
NCT05592444已完成不适用

Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2020年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
330
试验地点
2
主要终点
Contrast enhancement (Vascular attenuation)

研究概览

简要总结

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection.

Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.

详细描述

Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose.

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg).

Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Acquired CT images are identical for all participants. The study arm is unknown to all, except the radiographers (radiology technicians) performing the examination.

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

  • Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
  • Patients with clinical suspicion of disease of PE
  • Referral to CTPA diagnosis, treatment planning or follow-up.
  • Peripheral venous catheter (PVC) =/< 18 G

排除标准

  • Contraindication to iodinated contrast medium
  • Age < 18 years
  • Lack of informed consent
  • Pregnancy

结局指标

主要结局

Contrast enhancement (Vascular attenuation)

时间窗: Measured on the CT images from the examination performed at enrollment

Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination

次要结局

  • Contrast to noise ratio (CNR)(Measured on the CT images from the examination performed at enrollment)
  • Homogeneity of contrast enhancement (image noise)(Measured on the CT images from the examination performed at enrollment)
  • Signal to noise ratio (SNR)(Measured on the CT images from the examination performed at enrollment)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Maehre Lauritzen

Principal Investigator

University Hospital, Akershus

研究点 (2)

Loading locations...

相似试验