Multiparametric MRI for Characterization of Hepatocellular Carcinoma

NCT06999174 | Recruiting

• 2 other identifiers: 2025-207-f-SUniversity of Münster
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Multiparametric MRI; TACE; SIRT

Outcome Measures

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

  4 to 6 weeks after TACE, 3 months after SIRT

Study Arms (1)

HCC patients undergoing TACE or SIRT

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

Diagnostic Test: Multiparametric MRI

Interventions

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.

HCC patients undergoing TACE or SIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Clinic of Radiology, University of Münster

Münster, Germany

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Max Masthoff, MD

CONTACT

+492518343018; max.masthoff@ukmuenster.de

Philipp Schindler, MD

CONTACT

+492518343015; philipp.schindler@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

DE (1)