Effectiveness of Ultra-low-dose Chest CT With AI Based Denoising Solution

Not Applicable

• Conditions: Lung Diseases
• Interventions: Radiation: Low radiation dose CT; Radiation: Underwent ultra dose chest CT; Other: Artificial Intelligence based model

• Registration Number: NCT05398887
• Lead Sponsor: Intermed Hospital

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-01
• Study Start: 2022-06-15
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose Chest CT scan	Low radiation dose CT	Underwent low dose chest CT with 30% lower radiation dose Interventions: Radiation: Low radiation dose CT Other: Image quality analysis
Ultra low dose CT scan with Artificial Intelligence	Underwent ultra dose chest CT	Interventions: Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms
Ultra low dose CT scan with Artificial Intelligence	Artificial Intelligence based model	Interventions: Radiation: Low radiation dose CT Image quality Other: Deep-learning based contrast boosting algorithms

Primary Outcome Measures

Name	Time	Method
Detection rate of pulmonary conditions	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
Contrast media dose	Within 2 weeks after data collection	Administered contrast media dose in each patient

Secondary Outcome Measures

Name	Time	Method
Image contrast	Within 2 weeks after data collection	Signal to Noise, Noise and Edge-rise-distance on a five-point scale (1-5) with a higher score indicates better conspicuity.