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Clinical Trials/NCT05398887
NCT05398887UnknownNot Applicable

Utilization and Effectiveness of Ultra-low-dose Chest Computed Tomography Using Innovative CT Denoising Solution Based on Deep Learning Technology

Intermed Hospital0 sites200 target enrollmentStarted: June 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Primary Endpoint
Contrast media dose

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Low dose Chest CT scan

Active Comparator

Underwent low dose chest CT with 30% lower radiation dose

Interventions:

Radiation: Low radiation dose CT Other: Image quality analysis

Intervention: Low radiation dose CT (Radiation)

Ultra low dose CT scan with Artificial Intelligence

Experimental

Interventions:

Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms

Intervention: Underwent ultra dose chest CT (Radiation)

Ultra low dose CT scan with Artificial Intelligence

Experimental

Interventions:

Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms

Intervention: Artificial Intelligence based model (Other)

Outcomes

Primary Outcomes

Contrast media dose

Time Frame: Within 2 weeks after data collection

Administered contrast media dose in each patient

Detection rate of pulmonary conditions

Time Frame: Within 2 weeks after data collection

Pulmonary condition detection rate on low dose chest CT and ultra dose chest CT with artificial intelligence-based CT denoising solution by blinded reviewers

Secondary Outcomes

  • Image contrast(Within 2 weeks after data collection)

Investigators

Sponsor
Intermed Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bayarbaatar Bold

Principal Investigator, Bayarbaatar Bold, Diagnostic Radiologist, M.D, Intermed Hospital

Intermed Hospital

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