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

Thoracic Diseases Clinical Trial

— ART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971917
• Other study ID #: SNUHTruviewART-001
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 21, 2016
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Seoul National University Hospital
• Contact: Jin Mo Goo, M.D.
• Phone: 82-2-2072-2584
• Email: jmgoo[@]plaza.snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

Radiation:
• Chest x-ray image acquisition
Obtain a digital X-ray chest image of the patient
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)	- 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	Report composed based on analysis of clinical images accumulated over 6 months	No