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NCT05324046 Clinical Trial

Comparison Between LDCT With DL Recontruction and Standard Dose CT

Liver Metastases Clinical Trial

Official title:
Comparison of Low Dose Contrast Enhanced Abdominal CT With Deep Learning Reconstruction With Standard Dose CT With Iterative Reconstruction in Patients With Suspected Liver Metastases: A Prospective Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05324046
Other study ID # 2022-0410
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2, 2022
Est. completion date June 30, 2024

Study information
Verified date August 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 134
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - patients with underlying malignancy and suspicion of liver metastasis - patients with known liver metastasis and on follow-up - AND scheduled for contrast enhanced abdomen CT - signed informed consent Exclusion Criteria: - absolute or relative contra-indication for contrast-enhanced CT - diffuse infiltrative liver lesion or multiple (> 10) metastases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• contrast-enhanced abdomen CT
contrast-enhanced abdomen CT using dual-source CT scanner using A-tube (67% radiation) and B-tube (33% radiation). full dose CT data (A +B tubes, 100%) are reconstructed with iterative reconstruction (conventional) low dose CT data (A-tube only, B-tube only) are reconstructed with deep learning commercially available software. images are reconstructed using full dose (A- & B- tubes) and smaller dose (A-tube only, B-tube only)

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary liver lesion conspicuity graded on a five-point scale (1-5) with higher score indicates a better conscpicuity. 6 months after the CT scan
Secondary liver lesion detectability liver lesion detection rate on standard dose CT and low dose CT by blinded reviewers 6 months after the CT scan
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