High Resolution HBA-MRI Using Deep Learning Reconstruction

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05182099

Collaborator

GE Healthcare (Industry)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare image qualities between conventionally reconstructed MRI sequences and deep-learning reconstructed MRI sequences from the same data in patients who undergo Gd-EOB-DTPA enhanced liver MRI. The AIRTM deep learning sequence is applicable for various MRI sequences including T2-weighted image (T2WI), T1-weighted image and diffusion-weighted image (DWI). We plan to perform intra-individual comparisons of the image qualities between two reconstructed image datasets.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Magnetic Resonance Imaging Deep Learning	Diagnostic Test: Liver MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

blinded to the reconstruction types

Primary Purpose:

Diagnostic

Official Title:

AIRTM Deep Learning Reconstruction of Abdominal High Resolution Gd-EOB-DTPA Enhanced MRI in Patients With Suspicious Focal Liver Lesions: Image Quality Assessment

Actual Study Start Date :

Jan 10, 2022

Actual Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Conventional image reconstruction Gd-EOB-DTPA enhanced liver MRI images are reconstructed using a conventional image reconstruction algorithm. It is automatically generated from a MRI console after the examination.	Diagnostic Test: Liver MRI Gd-EOB-DTPA enhanced MRI consists of T2-weighted image (T2WI), diffusion weighted image (DWI) and precontrast T1-weighted image (T1WI), dynamic T1WI (arterial, portal and transitional phases), and hepatobiliary phase.
Active Comparator: Deep learning image reconstruction Gd-EOB-DTPA enhanced liver MRI images are reconstructed using a deep learning based image reconstruction algorithm (AIRTM). It is additionally generated aside from the conventional images. For obtaining the images, we will use the same MRI raw data which is used for conventional image reconstruction.	Diagnostic Test: Liver MRI Gd-EOB-DTPA enhanced MRI consists of T2-weighted image (T2WI), diffusion weighted image (DWI) and precontrast T1-weighted image (T1WI), dynamic T1WI (arterial, portal and transitional phases), and hepatobiliary phase.

Arm

Intervention/Treatment

Other: Conventional image reconstruction

Gd-EOB-DTPA enhanced liver MRI images are reconstructed using a conventional image reconstruction algorithm. It is automatically generated from a MRI console after the examination.

Diagnostic Test: Liver MRI

Gd-EOB-DTPA enhanced MRI consists of T2-weighted image (T2WI), diffusion weighted image (DWI) and precontrast T1-weighted image (T1WI), dynamic T1WI (arterial, portal and transitional phases), and hepatobiliary phase.

Active Comparator: Deep learning image reconstruction

Gd-EOB-DTPA enhanced liver MRI images are reconstructed using a deep learning based image reconstruction algorithm (AIRTM). It is additionally generated aside from the conventional images. For obtaining the images, we will use the same MRI raw data which is used for conventional image reconstruction.

Diagnostic Test: Liver MRI

Outcome Measures

Primary Outcome Measures

Overall image quality of arterial phase [3 months after enrollment completion]
qualitative assessment of arterial phase on a five point scale (highest score indicates better image quality)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

older than 20 years old
scheduled for Gd-EOB-DTPA enhanced liver MRI at a 3T scanner (Premier, GE Healthcare) in our institution
signed informed consent

Exclusion Criteria:

younger than 20 years old
any absolute/relative contrast indication of Gd-EOB-DTPA enhanced MRI
history of transient dyspnea after Gd-EOB-DTPA administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital
GE Healthcare

Investigators

Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05182099

Other Study ID Numbers:

2021-3044

First Posted:

Jan 10, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Apr 5, 2022