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NCT Number: NCT06999174

Multiparametric MRI for Characterization of Hepatocellular Carcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Radiology, University of Münster

Münster, Germany

Location status: Recruiting

Location contact

Emily Hoffmann, MD

PRINCIPAL_INVESTIGATOR

Max Masthoff, MD

CONTACT

[email protected]

+492518343018

Max Masthoff, MD

PRINCIPAL_INVESTIGATOR

Philipp Schindler, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multiparametric MRI

Diagnostic Test

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 outcomes

  1. Correlation of multiparametric MRI parameters with early therapy response

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Max Masthoff, MD

CONTACT

[email protected]

+492518343018

Philipp Schindler, MD

CONTACT

[email protected]

+492518343015

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 31, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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