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
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
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- Not able or willing to provide Informed Consent, or consent is withdrawn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
NCT ID
NCT02971917
First Posted
November 15, 2016
Last Updated
November 21, 2016
Sponsor
Seoul National University Hospital
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
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