NCT05550012

Brief Summary

CT-enhanced scans are routine imaging modality for the diagnosis and follow-up of liver disease. However, this means that patients will receive more radiation dose. Therefore, it is necessary to reduce the radiation dose received by patients as much as possible. Deep learning-based reconstruction algorithms have been introduced to improve image quality recently. For many years, researchers attempt to maintain image quality using an advanced method while reducing radiation dose. Recently, a new deep-learning based iterative reconstruction algorithm, namely artificial intelligence iterative reconstruction (AIIR, United Imaging Healthcare, Shanghai, China) has been introduced. In this study, we evaluate the image and diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 14, 2022

Last Update Submit

September 18, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • signal-to-noise ratio (SNR)

    Evaluate the image qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT

    6 months

  • contrast to noise ratio (CNR)

    Evaluate the image qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT

    6 months

  • diagnostic confidence

    Evaluate the diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT

    6 months

Study Arms (2)

standard-dose CT

NO INTERVENTION

those patients undergo standard-dose liver CT in portal vein and delayed phase

low-dose CT

EXPERIMENTAL

those patients undergo low-dose liver CT in portal vein and delayed phase

Other: low-dose CT

Interventions

those patients undergo low-dose liver CT in portal vein and delayed phase.

low-dose CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • those scheduled for contrast-enhanced liver CT

You may not qualify if:

  • images affected by artifacts (motion or implants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital (The First Affiliated Hospital of Shandong First Medical University)

Jinan, Shandong, China

Location

Study Officials

  • Qingshi Zeng

    Qianfoshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 22, 2022

Study Start

September 30, 2022

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations