NCT07010588Not yet recruiting
Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1389 (estimated)
- First submitted
- 19 May 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07010588
What you commit to
- Study type: Interventional
- Planned participants: 1389
- From Jun 2025 to the primary completion date, Jun 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous liver cancer diagnosis.
Other illness
- Baseline screening at enrollment diagnosed with liver cancer.
- History of other malignant tumors.
Age
- Clinically diagnosed severe heart/lung disease or uncontrolled comorbidities, with investigator-judged life expectancy \< 2 years.
Other
- Child-Pugh score ≥ 10 (class C).
- Pregnant or lactating women.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Union Hospital, Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Affiliated Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Handan Central Hospital Coordinator of this site? Confirm its status | Handan | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Tianjin Second People's Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| People's Hospital of Xishuangbanna Dai Autonomous Prefecture Coordinator of this site? Confirm its status | Xishuangbanna Dai Autonomous Prefecture | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.