Liver DiseasesNCT05182099
High Resolution HBA-MRI Using Deep Learning Reconstruction
A study testing Liver MRI in people with Liver Diseases and Magnetic Resonance Imaging, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Diseases, Magnetic Resonance Imaging, Deep Learning
- What is being tested?
- Liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Liver MRI
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall image quality of arterial phase
qualitative assessment of arterial phase on a five point scale (highest score indicates better image quality)
Measured: 3 months after enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Mar 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182099
- Sponsor's protocol ID
- 2021-3044
- Status last verified
- May 2023
- First submitted
- 16 Dec 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05182099
- Acronym / sponsor ID
- 2021-3044
- Conditions
- Liver Diseases, Magnetic Resonance Imaging, Deep Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional image reconstruction | Other | Diagnostic Test: Liver MRIGd-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. |
| Deep learning image reconstruction | Active comparator | Diagnostic Test: Liver MRIGd-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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver MRIGd-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. | Diagnostic test | Conventional image reconstruction, Deep learning image reconstruction |
Primary outcome
Overall image quality of arterial phase
Time frame: 3 months after enrollment completion
qualitative assessment of arterial phase on a five point scale (highest score indicates better image quality)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver MRI in people with Liver Diseases and Magnetic Resonance Imaging, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall image quality of arterial phase (time frame: 3 months after enrollment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.