A Clinical Study of TRUVIEW ART™(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph

Overview

To validate the following theory: "With TRUVIEW ART™ applied a detector's quantitative performance index, MTF(Modulation Transfer Function), is increased 20% or more". This is to examine the effect of the increased MTF index, whether it influences or not the interpreter's preference

Full Title of Study: “A Clinical Study of TRUVIEW ART(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2017

Detailed Description

Background of Study :

DRTECH Corp. has developed and applied for patenting the unique technology of TRUVIEW ART™. TRUVIEW ART™ is advanced image reconstruction technology that restores image quality from the side effects of scattering signals in indirect type scintillator detectors. It is an advanced image pre-processing technology that constructs signal scattering models (PSF) of indirect type detector scintillators. Image sharpness (MTF) is improved by predicting scattering models and eliminating the scattering signal.

Purpose of Research and Assumption :

Indirect conversion type detectors using scintillators are universal in today's diagnostic imaging area. However, they have a disadvantage of signal scattering compared with direct conversion type detectors. TRUVIEW ART™(Advanced Reconstruction Technology) can restore images from the scattering problems. The purpose of this study is to verify how well it improves the usefulness in clinical diagnostic imaging. Evaluation will measure the improvements in MTF, which is the quantitative performance index of a detector.

Interventions

  • Radiation: Chest x-ray image acquisition
    • Obtain a digital X-ray chest image of the patient
  • Radiation: Creation of TRUVIEW ART applied image
    • Application of TRUVIEW ART to the original chest x-ray image to create a new set of TRUVIEW ART applied image. Outcome: 2 versions of chest image Original Chest X-ray (w/o TRUVIEW ART) TRUVIEW ART applied image
  • Radiation: Comparison of TRUVIEW ART image with original image
    • Comparison of 2 versions of chest image side by side Performance evaluation may consist of detailed categories such as expression of chest structure, visibility level of pulmonary vascular system, etc. For all categories visibility and preference will be scored and each category will be analyzed to point out any statistical difference

Arms, Groups and Cohorts

  • Experimental: Clinical study of TRUVIEW ART
    • Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image

Clinical Trial Outcome Measures

Primary Measures

  • Qualitative research using Wilcoxon’s signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)
    • Time Frame: Report composed based on analysis of clinical images accumulated over 6 months
    • - Preference score : Eleven anatomic regions(unobscured lung, hilum, minor fissure, retrocardiac lung, lung projected below the diaphragm (subdiaphragmatic lung), azygoesophageal recess, heart border, rib, proximal airway, thoracic spine, and overall appearance) are evaluated. Each pair of images is ranked on a scale from one to five

Participating in This Clinical Trial

Inclusion Criteria

  • Adults of age 20 or higher
  • Person who is able to fully understand the clinical research procedures
  • Signed up agreement form
  • Patient who visits for Chest computed tomography (CT)

Exclusion Criteria

  • Subject is pregnant or suspicious of being pregnant
  • Not able or willing to provide Informed Consent, or consent is withdrawn
  • Not able to collect all required case information

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Mo Goo, Professor, Department of Radiology – Seoul National University Hospital
  • Overall Official(s)
    • Jin Mo Goo, M.D., Principal Investigator, Department of Radiology, Seoul National University Hospital
  • Overall Contact(s)
    • Jin Mo Goo, M.D., 82-2-2072-2584, jmgoo@plaza.snu.ac.kr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.