NCT05324046

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

April 4, 2022

Last Update Submit

August 16, 2023

Conditions

Keywords

CTmetastasisliver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • liver lesion detectability

    6 months after the CT scan

Study Arms (1)

Liver metastasis

Patients with suspicion of liver metastasis and scheduled for CT

Diagnostic Test: contrast-enhanced abdomen CT

Interventions

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)

Liver metastasis

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are referred to Radiology department for undergoing contrast-enhanced abdomen CT.

You may qualify if:

  • 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

You may not qualify if:

  • absolute or relative contra-indication for contrast-enhanced CT
  • diffuse infiltrative liver lesion or multiple (\> 10) metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Related Publications (1)

  • Lee TY, Yoon JH, Park JY, Park SH, Kim H, Lee CM, Choi Y, Lee JM. Intraindividual Comparison of Image Quality Between Low-Dose and Ultra-Low-Dose Abdominal CT With Deep Learning Reconstruction and Standard-Dose Abdominal CT Using Dual-Split Scan. Invest Radiol. 2025 Jul 1;60(7):454-462. doi: 10.1097/RLI.0000000000001151. Epub 2025 Jan 28.

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

June 2, 2022

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations