Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Multiparametric MRI, TACE, SIRT
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTMultiparametric MRI
Diagnostic multiparametric liver MRI, performed at three time points: before (≤14 days), 24 hours after, and 4-6 weeks after TACE or 3 months after SIRT.
Sponsors
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of multiparametric MRI parameters with early therapy response | 4 to 6 weeks after TACE, 3 months after SIRT | Evaluation of mpMRI features (e.g. ADC values, T1 relaxation time, enhancement patterns) in relation to early treatment response assessed 4-6 weeks after TACE or 3 months after SIRT using modified RECIST (mRECIST) criteria |
Countries
Germany
Contacts
Primary ContactMax Masthoff, MD
Backup ContactPhilipp Schindler, MD
Outcome results
None listed