Hepatocellular Carcinoma (HCC)SHORTNCT07010588
Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk
A study testing non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) in people with Hepatocellular Carcinoma (HCC) and Magnetic Resonance Imaging (MRI), run by Peking University People's Hospital at 12 sites in China.
Trial summary
Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. The currently recommended monitoring protocol involves biannual serum alpha-fetoprotein (AFP) testing combined with liver ultrasound (US) examinations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Magnetic Resonance Imaging (MRI), Randomized Controlled Trial
- What is being tested?
- non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,389 participants
- Where
- 12 sitesChina
- Study dates
- Jun 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) from department of medical administration, nation health commission of the People's Republic of China, with any one of the following high-risk factors for liver cancer: hepatitis B and/or C virus infection, excessive alcohol consumption, hepatic steatosis or metabolic dysfunction-associated liver disease, dietary exposure to aflatoxin B1, liver cirrhosis from other causes, or a family history of liver cancer, and an aMAP score (age⁃male⁃albi⁃platelets score) of 60-100 points.
- Liver disease patients with no evidence of suspected liver cancer in any imaging examination (liver US, contrast-enhanced CT, or contrast-enhanced MRI) within the past six months.
- Signed informed consent form.
Who cannot join
- History of previous liver cancer diagnosis.
- Baseline screening at enrollment diagnosed with liver cancer.
- Child-Pugh score ≥ 10 (class C).
- History of other malignant tumors.
- Pregnant or lactating women.
- Clinically diagnosed severe heart/lung disease or uncontrolled comorbidities, with investigator-judged life expectancy < 2 years.
Show all 9Show fewer
- Glomerular filtration rate < 50 mL/min.
- Inability to undergo (enhanced) MRI due to contraindications or relative contraindications.
- Poor compliance or unsuitability for the clinical trial as judged by the investigator.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100081
YI WANG, MD, 86-010-88325811, wang_yi@hsc.pku.edu.cn
China-Japan Union Hospital, Jilin University
Changchun, Jilin
Lin Liu, MD, 86-0431-84995684, liulin99@jlu.edu.cn
The Second Hospital of Jilin University
Changchun, Jilin
Jianhua Liu, MD, 86-0431-81133827, jian_hua@jlu.edu.cn
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality
Ping Cai, MD, 86-013228683331, 530305942@qq.com
Handan Central Hospital
Handan, Hebei
Shifeng Xiang, MD, 86-0310-2112789, xsf@live.cn
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yang Zhou, MD, 86-0451-85718915, zhouyang094@126.com
Qilu Hospital of Shandong University
Jinan, Shandong
Dexin Yu, MD, 86-0531-82169336, yudexin0330@sina.com
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Dapeng Hao, MD, 86-0532-82912628, haodp_2009@163.com
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Shengjuan Yao, MD, 86-013821953063, yaoshengjuan8206@163.com
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Fan Yang, MD, 86-0278-5726309, fyang@hust.edu.cn
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Yuelang Zhang, MD, 86-018991232590, 18991232590@163.com
People's Hospital of Xishuangbanna Dai Autonomous Prefecture
Xishuangbanna Dai Autonomous Prefecture, Yunnan
Yunhui Yang, MD, 86-018908814818, 54209535@qq.com
About this study
Official title: Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk: a Multi-centers, Randomized Controlled Open-label Trial
Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. The currently recommended monitoring protocol involves biannual serum alpha-fetoprotein (AFP) testing combined with liver ultrasound (US) examinations. However, conventional US demonstrates limited sensitivity in detecting early-stage HCC lesions.
MRI demonstrates high sensitivity in monitoring cirrhotic patients, but prolonged scanning time limits its routine clinical application. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.
Read more
The main question this clinical trial aims to answer is:
Can non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) detect more early-stage HCC lesions compared to US-based screening? Researchers will randomly divide the participants into three groups in a 1:1:1 ratio, with different surveillance strategies, focused on early HCC detection rates.
Read the detailed description
Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. Current guidelines recommend biannual AFP testing with liver ultrasound (US), but US has suboptimal sensitivity for early HCC detection.
MRI, while highly sensitive for monitoring cirrhotic patients, is limited in routine use due to long scan times.. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.
This is a multicenter, randomized controlled, open-label clinical trial targeting individuals at high risk for HCC, with a planned enrollment of 1,389 participants.
This trial aims to evaluate the effectiveness of three surveillance strategies-US, non-contrast abbreviated MRI (NC-AMRI; T2WI/DW sequences ) and enhanced abbreviated MRI (E-AMRI; using gadoxetic acid disodium with T2WI/DWI/HBP sequences)-in the active monitoring of HCC in high-risk populations.
Researchers will randomly assign participants (1:1:1) to three surveillance arms, followed by a 24-month long-term follow-up after the initial 18-month monitoring. The study includes 18 months of active surveillance and 24 months of extended follow-up.
The surveillance protocols of three groups:
- Control: Biannual US + AFP;
- NC-AMRI: Alternating NC-AMRI (T2WI/DWI) and US at 6/18 months;
- E-AMRI: Alternating E-AMRI (T2WI/DWI/HBP with gadoxetic acid) and US at 6/18 months.
All the participants will be followed up every 6 months according to the above-mentioned grouping and follow-up contents. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.
The primary focus of the clinic trial is the the early-stage (BCLC 0+A stage) HCC detection rate at 18th month post-enrollment, with pairwise comparisons among the three strategies.
χ² tests will compare detection rates, sensitivity, and specificity; Kaplan-Meier analysis with log-rank tests will evaluate survival. Survival analysis will include all HCC cases diagnosed in the study.
- Conditions
- Hepatocellular Carcinoma (HCC), Magnetic Resonance Imaging (MRI), Randomized Controlled Trial
- Being tested
- non-contrast abbreviated MRI (NC-AMRI), enhanced abbreviated MRI (E-AMRI)
- Keywords
- Hepatocellular carcinoma, magnetic resonance imaging, surveillance
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-contrast abbreviated MRI (NC-AMRI)Device
Non-contrast abbreviated MRI (NC-AMRI) examination include T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI), which takes 10 minutes approximately.
enhanced abbreviated MRI (E-AMRI)Device
E-AMRI examination (using gadoxetic acid disodium) including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI)and hepatobiliary phase (HBP) images, which takes 15 minutes approximately.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | After being enrolled, the participants will undergo a liver US examination and a serum AFP test every six months. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months. |
| Non-contrast abbreviated MRI group | Experimental | After the participants are enrolled, a serum AFP test and a NC-AMRI examination including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI) will be conducted at the 6th month. A liver US examination and a serum AFP test will be carried out at the 12th month. A serum AFP test and a NC-AMRI examination will be performed at the 18th month. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months. Receives: Device: non-contrast abbreviated MRI (NC-AMRI) |
| Enhanced abbreviated MRI group | Experimental | After the participants are enrolled, a serum AFP test and a E-AMRI examination (using gadoxetic acid disodium) including T2WI, DWI and hepatobiliary phase (HBP) images will be conducted at the 6th month. A liver US examination and a AFP test will be carried out at the 12th month. A serum AFP test and a E-AMRI examination will be performed at the 18th month. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue Receives: Device: enhanced abbreviated MRI (E-AMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the early-stage and very early-stage HCC detection rate
The primary outcome measure is the proportion of early-stage (BCLC 0+A stage) HCC diagnoses at 18th month, when a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.
Measured: at 18th month
Secondary outcomes (8)
18th month mortality rate in HCC patients
Number of deaths/population of HCC patients*100%
Measured: at 18th month
18th month survival rate in HCC patients
Number of survivals/population of HCC patients*100%
Measured: at 18th month
18th median survival time in HCC patients
Survival analysis will be performed using the Kaplan-Meier method for patients who developed HCC during the study period
Measured: at 18th month
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: at 18th month
the incremental cost-effectiveness ratio (ICER)
ICER (NC-AMRI)=(Total costs of NC-AMRI group)-(Total Costs of control group) / (Number of early-stage HCC patients detected in NC-AMRI group)- (Number of early-stage HCC patients detected in control group) .
ICER (E-AMRI)=(Total costs of E-AMRI group)-(Total Costs of control group) / (Number of early-stage HCC patients detected in E-AMRI group)- (Number of early-stage HCC patients detected in control group).
Total costs should include:
- Direct medical costs (Screening/diagnostic procedures e.g. MRI, blood tests)
- Direct non-medical costs (Transportation)
- Indirect costs
A below-threshold ICER confirms the cost-effectiveness of the new intervention.
Measured: at 18th month
Patient compliance to the study protocol
(Number of enrolled participants) - (Number of loss to follow-up cases)/(Number of enrolled participants)
Measured: at 18th month
Patient acceptability to the study protocol
Collect data by conducting a questionnaire survey among participants
Measured: at 18th month
early and very early-stage HCC detection at 42th month
Proportion of early and very early-stage HCC detection.
Measured: at 42th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Peking University People's 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute for Family Planning, China
- Responsible party
- Principal investigator, Wang Yi, Peking University People's Hospital
- Investigators
- Yi Wang, Professor, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010588
- Sponsor's protocol ID
- 2025-Z-43
- Acronym
- SHORT
- Status last verified
- Apr 2025
- First submitted
- 19 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SY, An J, Lim YS, Han S, Lee JY, Byun JH, Won HJ, Lee SJ, Lee HC, Lee YS. MRI With Liver-Specific Contrast for Surveillance of Patients With Cirrhosis at High Risk of Hepatocellular Carcinoma. JAMA Oncol. 2017 Apr 1;3(4):456-463. doi: 10.1001/jamaoncol.2016.3147.
PubMed 27657493Yu NC, Chaudhari V, Raman SS, Lassman C, Tong MJ, Busuttil RW, Lu DS. CT and MRI improve detection of hepatocellular carcinoma, compared with ultrasound alone, in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Feb;9(2):161-7. doi: 10.1016/j.cgh.2010.09.017. Epub 2010 Oct 1.
PubMed 20920597Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.
PubMed 29425931Colli A, Fraquelli M, Casazza G, Massironi S, Colucci A, Conte D, Duca P. Accuracy of ultrasonography, spiral CT, magnetic resonance, and alpha-fetoprotein in diagnosing hepatocellular carcinoma: a systematic review. Am J Gastroenterol. 2006 Mar;101(3):513-23. doi: 10.1111/j.1572-0241.2006.00467.x.
PubMed 16542288Simmons O, Fetzer DT, Yokoo T, Marrero JA, Yopp A, Kono Y, Parikh ND, Browning T, Singal AG. Predictors of adequate ultrasound quality for hepatocellular carcinoma surveillance in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Jan;45(1):169-177. doi: 10.1111/apt.13841. Epub 2016 Nov 8.
PubMed 27862091Wong LL, Reyes RJ, Kwee SA, Hernandez BY, Kalathil SC, Tsai NC. Pitfalls in surveillance for hepatocellular carcinoma: How successful is it in the real world? Clin Mol Hepatol. 2017 Sep;23(3):239-248. doi: 10.3350/cmh.2017.0008. Epub 2017 Jul 14.
PubMed 28706177
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk: a Multi-centers, Randomized Controlled Open-label Trial
- ClinicalTrials.gov ID
- NCT07010588
- Acronym / sponsor ID
- SHORT / 2025-Z-43
- Conditions
- Hepatocellular Carcinoma (HCC), Magnetic Resonance Imaging (MRI), Randomized Controlled Trial
- Keywords
- Hepatocellular carcinoma, magnetic resonance imaging, surveillance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,389 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- National Research Institute for Family Planning, China
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 Jun 2025 (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.
Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. The currently recommended monitoring protocol involves biannual serum alpha-fetoprotein (AFP) testing combined with liver ultrasound (US) examinations. However, conventional US demonstrates limited sensitivity in detecting early-stage HCC lesions.
MRI demonstrates high sensitivity in monitoring cirrhotic patients, but prolonged scanning time limits its routine clinical application. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.
The main question this clinical trial aims to answer is:
Can non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) detect more early-stage HCC lesions compared to US-based screening? Researchers will randomly divide the participants into three groups in a 1:1:1 ratio, with different surveillance strategies, focused on early HCC detection rates.
Detailed description
Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. Current guidelines recommend biannual AFP testing with liver ultrasound (US), but US has suboptimal sensitivity for early HCC detection.
MRI, while highly sensitive for monitoring cirrhotic patients, is limited in routine use due to long scan times.. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.
This is a multicenter, randomized controlled, open-label clinical trial targeting individuals at high risk for HCC, with a planned enrollment of 1,389 participants.
This trial aims to evaluate the effectiveness of three surveillance strategies-US, non-contrast abbreviated MRI (NC-AMRI; T2WI/DW sequences ) and enhanced abbreviated MRI (E-AMRI; using gadoxetic acid disodium with T2WI/DWI/HBP sequences)-in the active monitoring of HCC in high-risk populations.
Researchers will randomly assign participants (1:1:1) to three surveillance arms, followed by a 24-month long-term follow-up after the initial 18-month monitoring. The study includes 18 months of active surveillance and 24 months of extended follow-up.
The surveillance protocols of three groups:
- Control: Biannual US + AFP;
- NC-AMRI: Alternating NC-AMRI (T2WI/DWI) and US at 6/18 months;
- E-AMRI: Alternating E-AMRI (T2WI/DWI/HBP with gadoxetic acid) and US at 6/18 months.
All the participants will be followed up every 6 months according to the above-mentioned grouping and follow-up contents. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.
The primary focus of the clinic trial is the the early-stage (BCLC 0+A stage) HCC detection rate at 18th month post-enrollment, with pairwise comparisons among the three strategies.
χ² tests will compare detection rates, sensitivity, and specificity; Kaplan-Meier analysis with log-rank tests will evaluate survival. Survival analysis will include all HCC cases diagnosed in the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –After being enrolled, the participants will undergo a liver US examination and a serum AFP test every six months. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months. |
| Non-contrast abbreviated MRI group | Experimental | Device: non-contrast abbreviated MRI (NC-AMRI)After the participants are enrolled, a serum AFP test and a NC-AMRI examination including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI) will be conducted at the 6th month. A liver US examination and a serum AFP test will be carried out at the 12th month. A serum AFP test and a NC-AMRI examination will be performed at the 18th month. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months. |
| Enhanced abbreviated MRI group | Experimental | Device: enhanced abbreviated MRI (E-AMRI)After the participants are enrolled, a serum AFP test and a E-AMRI examination (using gadoxetic acid disodium) including T2WI, DWI and hepatobiliary phase (HBP) images will be conducted at the 6th month. A liver US examination and a AFP test will be carried out at the 12th month. A serum AFP test and a E-AMRI examination will be performed at the 18th month. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC. After the completion of 18 months surveillance, researchers will continue |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) from department of medical administration, nation health commission of the People's Republic of China, with any one of the following high-risk factors for liver cancer: hepatitis B and/or C virus infection, excessive alcohol consumption, hepatic steatosis or metabolic dysfunction-associated liver disease, dietary exposure to aflatoxin B1, liver cirrhosis from other causes, or a family history of liver cancer, and an aMAP score (age⁃male⁃albi⁃platelets score) of 60-100 points.
- Liver disease patients with no evidence of suspected liver cancer in any imaging examination (liver US, contrast-enhanced CT, or contrast-enhanced MRI) within the past six months.
- Signed informed consent form.
Key exclusion criteria (9 listed)
- History of previous liver cancer diagnosis.
- Baseline screening at enrollment diagnosed with liver cancer.
- Child-Pugh score ≥ 10 (class C).
- History of other malignant tumors.
- Pregnant or lactating women.
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 |
|---|---|---|
| non-contrast abbreviated MRI (NC-AMRI)Non-contrast abbreviated MRI (NC-AMRI) examination include T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI), which takes 10 minutes approximately. | Device | Non-contrast abbreviated MRI group |
| enhanced abbreviated MRI (E-AMRI)E-AMRI examination (using gadoxetic acid disodium) including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI)and hepatobiliary phase (HBP) images, which takes 15 minutes approximately. | Device | Enhanced abbreviated MRI group |
Primary outcome
the early-stage and very early-stage HCC detection rate
Time frame: at 18th month
The primary outcome measure is the proportion of early-stage (BCLC 0+A stage) HCC diagnoses at 18th month, when a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.
8 secondary outcomes
18th month mortality rate in HCC patients
Time frame: at 18th month
18th month survival rate in HCC patients
Time frame: at 18th month
18th median survival time in HCC patients
Time frame: at 18th month
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Time frame: at 18th month
the incremental cost-effectiveness ratio (ICER)
Time frame: at 18th month
Patient compliance to the study protocol
Time frame: at 18th month
Patient acceptability to the study protocol
Time frame: at 18th month
early and very early-stage HCC detection at 42th month
Time frame: at 42th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 27657493Kim SY, An J, Lim YS, Han S, Lee JY, Byun JH, Won HJ, Lee SJ, Lee HC, Lee YS. MRI With Liver-Specific Contrast for Surveillance of Patients With Cirrhosis at High Risk of Hepatocellular Carcinoma. JAMA Oncol. 2017 Apr 1;3(4):456-463. doi: 10.1001/jamaoncol.2016.3147.
- Background: PubMed 20920597Yu NC, Chaudhari V, Raman SS, Lassman C, Tong MJ, Busuttil RW, Lu DS. CT and MRI improve detection of hepatocellular carcinoma, compared with ultrasound alone, in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Feb;9(2):161-7. doi: 10.1016/j.cgh.2010.09.017. Epub 2010 Oct 1.
- Background: PubMed 29425931Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.
- Background: PubMed 16542288Colli A, Fraquelli M, Casazza G, Massironi S, Colucci A, Conte D, Duca P. Accuracy of ultrasonography, spiral CT, magnetic resonance, and alpha-fetoprotein in diagnosing hepatocellular carcinoma: a systematic review. Am J Gastroenterol. 2006 Mar;101(3):513-23. doi: 10.1111/j.1572-0241.2006.00467.x.
- Background: PubMed 27862091Simmons O, Fetzer DT, Yokoo T, Marrero JA, Yopp A, Kono Y, Parikh ND, Browning T, Singal AG. Predictors of adequate ultrasound quality for hepatocellular carcinoma surveillance in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Jan;45(1):169-177. doi: 10.1111/apt.13841. Epub 2016 Nov 8.
- Background: PubMed 28706177Wong LL, Reyes RJ, Kwee SA, Hernandez BY, Kalathil SC, Tsai NC. Pitfalls in surveillance for hepatocellular carcinoma: How successful is it in the real world? Clin Mol Hepatol. 2017 Sep;23(3):239-248. doi: 10.3350/cmh.2017.0008. Epub 2017 Jul 14.
Related trials for Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Yi Wang, Professor study chair
Peking University People's Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) in people with Hepatocellular Carcinoma (HCC) and Magnetic Resonance Imaging (MRI), run by Peking University People's Hospital at 12 sites 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Wang, MD (86-010-88325193, wang_yi@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the early-stage and very early-stage HCC detection rate (time frame: at 18th month). 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 NCT07010588, which also lists 6 linked publications.
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 8 Jun 2025.