Multiparametric MRI for Characterization of Hepatocellular Carcinoma

University Hospital Muenster

Status: Enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Diagnostic Test: Multiparametric MRI

Study type: Observational

Funder types: Other

Identifiers

NCT06999174

University of Münster (Other Grant/Funding Number)

2025-207-f-S

Details and patient eligibility

About

This prospective observational study investigates using multiparametric magnetic resonance imaging (MRI) to improve the characterization and management of therapy for hepatocellular carcinoma (HCC). The goal is to evaluate whether advanced MRI parameters can support noninvasive diagnostic assessments and personalized treatment plans for patients with HCC. The study is being conducted at a single university center in Germany and includes adult patients with confirmed or suspected HCC. Participants will undergo standardized multiparametric MRI examinations, and the imaging data will be correlated with clinical, pathological, and therapeutic outcomes. No study-specific interventions or medications will be administered.

Full description

This prospective, monocentric, observational study evaluates the clinical utility of multiparametric magnetic resonance imaging (mpMRI) in the characterization and management of hepatocellular carcinoma (HCC). The study focuses on how advanced MRI techniques-such as diffusion-weighted imaging (DWI), dynamic contrast-enhanced MRI (DCE-MRI), and quantitative mapping (T1/T2)-can provide functional insights into tumor biology.

Conducted at a German university hospital, the study investigates whether mpMRI can improve diagnostic precision and assist in therapeutic decision-making for patients undergoing locoregional treatments like transarterial chemoembolization (TACE) or selective internal radiotherapy (SIRT).

By integrating multiple MRI biomarkers, the study aims to explore correlations between imaging features and treatment response. Imaging protocols follow current clinical standards, and the study introduces no investigational agents. Radiological evaluations are performed by expert radiologists, and statistical analysis is pre-specified. The study complies with ethical and data protection standards.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Confirmed or suspected diagnosis of HCC
• Scheduled to receive TACE or SIRT as part of standard clinical care
• Eligibility for liver MRI
• Willing and able to provide written informed consent

Exclusion criteria

• Contraindications to MRI (e.g., pacemakers, ferromagnetic implants, severe claustrophobia)
• Known allergy or intolerance to gadolinium-based contrast agents
• Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²
• Pregnancy or breastfeeding
• Inability to provide informed consent

Trial design

128 participants in 1 patient group

HCC patients undergoing TACE or SIRT

Description:

Patients with hepatocellular carcinoma scheduled for TACE or SIRT, undergoing multiparametric MRI at three defined time points.

Treatment:

Diagnostic Test: Multiparametric MRI