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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
Intermed Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 25, 2022
    Last Updated
    May 30, 2022
    Sponsor
    Intermed Hospital
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    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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