High Resolution HBA-MRI Using Deep Learning Reconstruction

NCT05182099 | Unknown DMC

• 1 other identifier: 2021-3044
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Diseases; Magnetic Resonance Imaging; Deep Learning

Outcome Measures

Primary Outcomes (1)

• Overall image quality of arterial phase

  qualitative assessment of arterial phase on a five point scale (highest score indicates better image quality)

  3 months after enrollment completion

Study Arms (2)

Conventional image reconstruction

OTHER

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

Deep learning image reconstruction

ACTIVE COMPARATOR

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

Interventions

Liver MRI DIAGNOSTIC_TEST

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.

Conventional image reconstruction; Deep learning image reconstruction

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• GE Healthcare: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded to the reconstruction types
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 10, 2022
• Study Start: January 10, 2022
• Primary Completion: March 30, 2022
• Study Completion: September 30, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)