Hepatocellular Carcinoma (HCC)AMRI; LIRADSNCT06663904
Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis
An observational study of Hepatocellular Carcinoma (HCC), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 938 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive participants at risk for developing HCC (ie, liver cirrhosis of any etiologies or chronic hepatitis virus infections) who underwent gadoxetic acid-enhanced MRI between January 2020 and December 2022 and are eligible for inclusion in this study.
Who may be able to join
- no previous history of HCC treatment
- no history of any other underlying malignancy besides HCC.
Who cannot join
- For HCC group: (a) without preoperative MRI within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of HCC smaller than 1cm; (e) outside of Milan Criteria; and (f) suboptimal imaging quality.
- For non-HCC group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Validation of Different Abbreviated MRI Protocols for Early-Stage Hepatocellular Carcinoma Diagnosis Using Main and Ancillary Features of LI-RADS
Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC.
Read the detailed description
This retrospective study enrolled untreated patients at risk for developing HCC who underwent gadoxetic acid-enhanced MRI from three independent cohorts from January 2020 to December 2022. Three AMRI protocols were extracted from the complete liver MRI protocol, including non-contrast (NC-AMRI), hepatobiliary phase (HBP-AMRI); and dynamic contrast-enhanced (DCE-AMRI). Two readers at each cohort independently interpreted each AMRI based on ancillary and main features from the Liver Imaging Reporting and Data System (LI-RADS) version 2018. For DCE-AMRI, two established algorithms were employed: modified LI-RADS (DCE-AMRIm) and LI-RADS v2018 (DCE-AMRIv2018). Non-HCCs were ascertained based on histologic and clinical follow-up data, while early-stage HCCs were confirmed post-operatively. Patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC group | No previous treatments were performed before MRI examination of patients. | |
| Non-HCC group | No previous treatments were performed before MRI examination of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with HCC
Measured: immediately after the surgery
Secondary outcomes (1)
Number of patients with non-HCC
Measured: immediately after pathology from postoperative or biopsy samples, or clinical diagnosis after at least 1 year without imaging indications of liver malignancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 938 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanjin Qin, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663904
- Sponsor's protocol ID
- SYSUFAH2021124
- Other IDs
- 82271958, 2024A1515012149, 2023A15150110
- Acronym
- AMRI; LIRADS
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated for this study are from the corresponding author upon reasonable request.
Publications
Qin Y, Zhang J, Xu D, Zhou X, Ling Z, Li L, Zhao Q, Dong Z, Wang J, Cai HS, Li H, Zhang LG, Feng ST. Diagnosis of Hepatocellular Carcinoma Using Gadoxetic Acid-Enhanced MRI Based on LI-RADS Version 2018 and LI-RADS Modifications. Liver Int. 2025 Nov;45(11):e70366. doi: 10.1111/liv.70366.
PubMed 41042775
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of Different Abbreviated MRI Protocols for Early-Stage Hepatocellular Carcinoma Diagnosis Using Main and Ancillary Features of LI-RADS
- ClinicalTrials.gov ID
- NCT06663904
- Acronym / sponsor ID
- AMRI; LIRADS / SYSUFAH2021124
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 938 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Oct 2024 (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.
Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC.
Detailed description
This retrospective study enrolled untreated patients at risk for developing HCC who underwent gadoxetic acid-enhanced MRI from three independent cohorts from January 2020 to December 2022. Three AMRI protocols were extracted from the complete liver MRI protocol, including non-contrast (NC-AMRI), hepatobiliary phase (HBP-AMRI); and dynamic contrast-enhanced (DCE-AMRI). Two readers at each cohort independently interpreted each AMRI based on ancillary and main features from the Liver Imaging Reporting and Data System (LI-RADS) version 2018. For DCE-AMRI, two established algorithms were employed: modified LI-RADS (DCE-AMRIm) and LI-RADS v2018 (DCE-AMRIv2018). Non-HCCs were ascertained based on histologic and clinical follow-up data, while early-stage HCCs were confirmed post-operatively. Patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC group | – | –No previous treatments were performed before MRI examination of patients. |
| Non-HCC group | – | –No previous treatments were performed before MRI examination of patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive participants at risk for developing HCC (ie, liver cirrhosis of any etiologies or chronic hepatitis virus infections) who underwent gadoxetic acid-enhanced MRI between January 2020 and December 2022 and are eligible for inclusion in this study.
Key inclusion criteria (2 listed)
- no previous history of HCC treatment
- no history of any other underlying malignancy besides HCC.
Key exclusion criteria (2 listed)
- For HCC group: (a) without preoperative MRI within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of HCC smaller than 1cm; (e) outside of Milan Criteria; and (f) suboptimal imaging quality.
- For non-HCC group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with HCC
Time frame: immediately after the surgery
1 secondary outcome
Number of patients with non-HCC
Time frame: immediately after pathology from postoperative or biopsy samples, or clinical diagnosis after at least 1 year without imaging indications of liver malignancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 41042775Qin Y, Zhang J, Xu D, Zhou X, Ling Z, Li L, Zhao Q, Dong Z, Wang J, Cai HS, Li H, Zhang LG, Feng ST. Diagnosis of Hepatocellular Carcinoma Using Gadoxetic Acid-Enhanced MRI Based on LI-RADS Version 2018 and LI-RADS Modifications. Liver Int. 2025 Nov;45(11):e70366. doi: 10.1111/liv.70366.
- Individual participant dataSharing planned: No. All data generated for this study are from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with HCC (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663904, which also lists 1 linked publication.
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 29 Oct 2024.