Effectiveness of Ultra-low-dose Chest CT With AI Based Denoising Solution
Primary Purpose
Lung Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low radiation dose CT
Underwent ultra dose chest CT
Artificial Intelligence based model
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Diseases focused on measuring Computed tomography, Artificial Intelligence, Denoising technique, Ultra-low-dose Computed tomography
Eligibility Criteria
Inclusion Criteria:
- Patients aged over 18-year-old
- Patients undergoing CT Chest for all purpose
Exclusion Criteria:
- Age less than 18 years
- Any suspicion of pregnancy
- History of thoracic surgery or placement of the metallic device in the thorax
- An inability to hold respiration during CT
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low dose Chest CT scan
Ultra low dose CT scan with Artificial Intelligence
Arm Description
Underwent low dose chest CT with 30% lower radiation dose Interventions: Radiation: Low radiation dose CT Other: Image quality analysis
Interventions: Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms
Outcomes
Primary Outcome Measures
Detection rate of pulmonary conditions
Pulmonary condition detection rate on low dose chest CT and ultra dose chest CT with artificial intelligence-based CT denoising solution by blinded reviewers
Contrast media dose
Administered contrast media dose in each patient
Secondary Outcome Measures
Image contrast
Signal to Noise, Noise and Edge-rise-distance on a five-point scale (1-5) with a higher score indicates better conspicuity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05398887
Brief Title
Effectiveness of Ultra-low-dose Chest CT With AI Based Denoising Solution
Official Title
Utilization and Effectiveness of Ultra-low-dose Chest Computed Tomography Using Innovative CT Denoising Solution Based on Deep Learning Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermed Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the study is to evaluate the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of ULDCT coupling with innovative vendor-neutral CT denoising solution based on deep learning technology.
Detailed Description
Considering lung cancer-related public health challenges, a reliable lung cancer screening method for high-risk cohorts in Mongolia is needed. Thus, our study aims to assess the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of ULDCT coupling with artificial intelligence based CT denoising technique among various patient groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Computed tomography, Artificial Intelligence, Denoising technique, Ultra-low-dose Computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose Chest CT scan
Arm Type
Active Comparator
Arm Description
Underwent low dose chest CT with 30% lower radiation dose
Interventions:
Radiation: Low radiation dose CT Other: Image quality analysis
Arm Title
Ultra low dose CT scan with Artificial Intelligence
Arm Type
Experimental
Arm Description
Interventions:
Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms
Intervention Type
Radiation
Intervention Name(s)
Low radiation dose CT
Intervention Description
Underwent low dose chest CT with 30% lower radiation dose
Intervention Type
Radiation
Intervention Name(s)
Underwent ultra dose chest CT
Intervention Description
Underwent ultra dose chest CT with 90% lower radiation dose
Intervention Type
Other
Intervention Name(s)
Artificial Intelligence based model
Intervention Description
Deep-learning based contrast boosting algorithms
Primary Outcome Measure Information:
Title
Detection rate of pulmonary conditions
Description
Pulmonary condition detection rate on low dose chest CT and ultra dose chest CT with artificial intelligence-based CT denoising solution by blinded reviewers
Time Frame
Within 2 weeks after data collection
Title
Contrast media dose
Description
Administered contrast media dose in each patient
Time Frame
Within 2 weeks after data collection
Secondary Outcome Measure Information:
Title
Image contrast
Description
Signal to Noise, Noise and Edge-rise-distance on a five-point scale (1-5) with a higher score indicates better conspicuity.
Time Frame
Within 2 weeks after data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged over 18-year-old
Patients undergoing CT Chest for all purpose
Exclusion Criteria:
Age less than 18 years
Any suspicion of pregnancy
History of thoracic surgery or placement of the metallic device in the thorax
An inability to hold respiration during CT
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayarbaatar Bold, M.D
Phone
976-99063486
Email
bayarbaatar99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khulan Khurelsukh, M.D, MSc
Phone
976-88010440
Email
khulan.kh@intermed.mn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khulan Khurelsukh, M.D, MSc
Organizational Affiliation
Intermed Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Delgerekh Sainjargal, M.D, MSc
Organizational Affiliation
Intermed Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bayarbaatar Bold, M.D
Organizational Affiliation
Intermed Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Ultra-low-dose Chest CT With AI Based Denoising Solution
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