Multiparametric MRI for Characterization of Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients (≥18 years) with confirmed or suspected HCC who are scheduled for TACE or SIRT as part of routine clinical care at a tertiary academic center. Patients must be eligible for liver MRI and provide informed consent. The population includes treatment-naive as well as previously treated individuals, as long as they meet the inclusion criteria. Recruitment is non-randomized and consecutive.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multiparametric MRI
Diagnostic testDiagnostic 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.
Treatment groups
128 Participants
are divided into 1 treatment groupGroup A: HCC patients undergoing TACE or SIRT1 intervention
Trial outcomes
Primary outcomes
1
Correlation of multiparametric MRI parameters with early therapy response
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
Time frame
4 to 6 weeks after TACE, 3 months after SIRTSponsors and contacts
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Source ClinicalTrials.gov