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临床试验/NCT03033615
NCT03033615Unknown不适用

Prospective Review of CT Imaging Data Comparing Quality of Low-Radiation-Dose Images Post-Processed With Iterative Reconstruction Software vs. Machine Learning (AlgoMedica PixelShine) Software

AlgoMedica, Inc.0 个研究点目标入组 20 人开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Visual Image Quality as Assessed by Image Noise Reduction

研究概览

简要总结

This study will compare the quality of CT images acquired with very low-dose radiation and processed with commercially available software vs. PixelShine processed images. It would potentially allow imaging facilities to acquire CT scans using lower doses of radiation without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose radiation has the potential to enhance patient safety and has significant implications in imaging practices.

详细描述

Patients receiving CT scans as part of their standard treatment will be asked to consent to an additional 5 minutes of imaging using very low-dose radiation prior to the conventional-dose CT scan. The prospective review will be performed in two cohorts: Chest CT scans and abdominal CT scans.

Anonymized images will be processed by conventional CT software and compared to the same images processed with machine-learning-based PixelShine. A board-certified radiologist will assess the noise and visual quality of the imaging data.

Study patients will receive approximately 10% more dose than a standard CT scan by participating in the study. There are no known short-term safety issues associated with this study. The study-related very low dose radiation is at a level far below that used for conventional x-ray imaging. The study has been approved by the Radiation Safety Committee as part of the review process.

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
Single (Participant)

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

  • Patients must be 18 years of age or older
  • Patients must be able and willing to consent to participate in this project
  • Patients will be scheduled for a standard of care CT scan

排除标准

  • This study does not investigate either a specific disease or a specific patient population-it only examines and compares images obtained at low radiation exposure post-processed with Algomedica's PixelShine software with conventionally processed images
  • All other patients will be excluded

结局指标

主要结局

Visual Image Quality as Assessed by Image Noise Reduction

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

Comparison of image noise

次要结局

  • Image Resolution as Assessed by Size of Detected Lesions(Through study completion, an average of 1 month)

研究者

申办方类型
Industry
责任方
Sponsor

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