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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,389
- 试验地点
- 12
- 主要终点
- the early-stage and very early-stage HCC detection rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
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
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.
干预措施: non-contrast abbreviated MRI (NC-AMRI) (Device)
Enhanced abbreviated MRI group
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
干预措施: enhanced abbreviated MRI (E-AMRI) (Device)
结局指标
主要结局
the early-stage and very early-stage HCC detection rate
时间窗: 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.
次要结局
- 18th month survival rate in HCC patients(at 18th month)
- 18th median survival time in HCC patients(at 18th month)
- 18th month mortality rate 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)
- Patient acceptability to the study protocol(at 18th month)
- Patient compliance to the study protocol(at 18th month)
- early and very early-stage HCC detection at 42th month(at 42th month)
研究者
Wang Yi
Professor
Peking University People's Hospital