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 (SHORT)

NCT07010588 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Peking University People's Hospital
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	1389
Start date	2025-06
Completion	2030-06

Conditions

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

Interventions

• non-contrast abbreviated MRI (NC-AMRI)
• enhanced abbreviated MRI (E-AMRI)

Primary outcomes

• the early-stage and very early-stage HCC detection rate — 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.

Countries

China