Menu
Recruiting NCT06999174

Multiparametric MRI for Characterization of Hepatocellular Carcinoma

Observational Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multiparametric MRI.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multiparametric MRI for Optimized Imaging-based Characterization and Therapy Management of Hepatocellular Carcinoma

Overview

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 test Multiparametric 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.

Primary outcome measures

  • Correlation of multiparametric MRI parameters with early therapy response [Time frame: 4 to 6 weeks after TACE, 3 months after SIRT]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Clinic of Radiology, University of Münster — Münster

Publications

  • Zhang C, Chen X, Wang J, Luo T. Diagnostic values of contrast-enhanced MRI and contrast-enhanced CT for evaluating the response of hepatocellular carcinoma after transarterial chemoembolisation: a meta-analysis. BMJ Open. 2024 Apr 5;14(4):e070364. doi: 10.1136/bmjopen-2022-070364. PMID 38580362
  • Wang L, Yang JD, Yoo CC, Lai KKY, Braun J, McGovern DPB, Xie Y, Pandol SJ, Lu SC, Li D. Magnetic resonance imaging for characterization of hepatocellular carcinoma metabolism. Front Physiol. 2022 Dec 15;13:1056511. doi: 10.3389/fphys.2022.1056511. eCollection 2022. PMID 36589457
  • Hoffmann E, Masthoff M, Kunz WG, Seidensticker M, Bobe S, Gerwing M, Berdel WE, Schliemann C, Faber C, Wildgruber M. Multiparametric MRI for characterization of the tumour microenvironment. Nat Rev Clin Oncol. 2024 Jun;21(6):428-448. doi: 10.1038/s41571-024-00891-1. Epub 2024 Apr 19. PMID 38641651

Identifiers

NCT: NCT06999174 · 2025-207-f-S · University of Münster

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗