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

Not Applicable

• Conditions: Thoracic Diseases
• Interventions: Radiation: Chest x-ray image acquisition; Radiation: Creation of TRUVIEW ART applied image; Radiation: Comparison of TRUVIEW ART image with original image

• Registration Number: NCT02971917
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical study of TRUVIEW ART	Creation of TRUVIEW ART applied image	Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image
Clinical study of TRUVIEW ART	Chest x-ray image acquisition	Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image
Clinical study of TRUVIEW ART	Comparison of TRUVIEW ART image with original image	Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image

Primary Outcome Measures

Name	Time	Method
Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of