search
Back to results

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

Primary Purpose

Thoracic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chest x-ray image acquisition
Creation of TRUVIEW ART applied image
Comparison of TRUVIEW ART image with original image
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Diseases focused on measuring Chest radiography, Image improvements, Image Reconstruction, Preprocessing, MTF

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Not able or willing to provide Informed Consent, or consent is withdrawn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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clinical study of TRUVIEW ART

Arm Description

Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image

Outcomes

Primary Outcome 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)
- 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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
November 21, 2016
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02971917
Brief Title
A Clinical Study of TRUVIEW ART™(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph
Acronym
ART
Official Title
A Clinical Study of TRUVIEW ART(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases
Keywords
Chest radiography, Image improvements, Image Reconstruction, Preprocessing, MTF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical study of TRUVIEW ART
Arm Type
Experimental
Arm Description
Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image
Intervention Type
Radiation
Intervention Name(s)
Chest x-ray image acquisition
Intervention Description
Obtain a digital X-ray chest image of the patient
Intervention Type
Radiation
Intervention Name(s)
Creation of TRUVIEW ART applied image
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Comparison of TRUVIEW ART image with original image
Intervention Description
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
Primary Outcome Measure Information:
Title
Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)
Description
- 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
Time Frame
Report composed based on analysis of clinical images accumulated over 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Mo Goo, M.D.
Phone
82-2-2072-2584
Email
jmgoo@plaza.snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Mo Goo, M.D.
Organizational Affiliation
Department of Radiology, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Yeon Ahn, M.D.
Phone
82-2-2072-2254
Email
ddodola323@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs