Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk

NCT07010588 | Not Yet Recruiting

• 1 other identifier: 2025-Z-43
• Study Type: interventional
• Target: 1,389
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Hepatocellular Carcinoma (HCC); Magnetic Resonance Imaging (MRI); Randomized Controlled Trial

Keywords

Hepatocellular carcinoma; magnetic resonance imaging; surveillance

Outcome Measures

Primary Outcomes (1)

• 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.

  at 18th month

Secondary Outcomes (8)

• 18th month mortality rate in HCC patients

  at 18th month

• 18th month survival rate in HCC patients

  at 18th month

• 18th median survival time in HCC patients

  at 18th month

• Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

  at 18th month

• the incremental cost-effectiveness ratio (ICER)

  at 18th month

Study Arms (3)

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.

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

Device: enhanced abbreviated MRI (E-AMRI)

Interventions

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.

Non-contrast abbreviated MRI group

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.

Enhanced abbreviated MRI group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• National Research Institute for Family Planning: collaborator

Study Sites (12)

Peking University People's Hospital

Beijing, Beijing Municipality, 100081, China

Location

The First Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Location

Handan Central Hospital

Handan, Hebei, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

China-Japan Union Hospital, Jilin University

Changchun, Jilin, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Location

People's Hospital of Xishuangbanna Dai Autonomous Prefecture

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Location

Related Publications (6)

• 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.

  PMID: 27657493 BACKGROUND

• Yu 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.

  PMID: 20920597 BACKGROUND

• Tzartzeva 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.

  PMID: 29425931 BACKGROUND

• Colli 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.

  PMID: 16542288 BACKGROUND

• Simmons 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.

  PMID: 27862091 BACKGROUND

• Wong 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.

  PMID: 28706177 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yi Wang, Professor

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yi Wang, MD

CONTACT

86-010-88325193; wang_yi@hsc.pku.edu.cn

Rong Liu, MD

CONTACT

86-015210594133; lrr19910222@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-04

Locations

CN (12)