Clinical trial NCT06999174: Multiparametric MRI for Characterization of Hepatocellular Carcinoma
Official title: Multiparametric MRI for Optimized Imaging-based Characterization and Therapy Management of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Multiparametric MRI
TACE
SIRT
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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, non-interventional, observational study investigates the clinical utility of multiparametric magnetic resonance imaging (mpMRI) in optimizing the characterization and management of therapy for hepatocellular carcinoma (HCC). The study is being conducted at a German university hospital that specializes in liver imaging and oncology.

The study will enroll patients with confirmed or suspected HCC who are scheduled to undergo locoregional therapy, specifically transarterial chemoembolization (TACE) or selective internal radiotherapy (SIRT). This study aims to evaluate whether advanced MRI parameters can improve tumor characterization and predict the therapeutic response.

The multiparametric MRI protocol includes:

* T1-weighted and T2-weighted sequences
* Diffusion-weighted imaging (DWI) with apparent diffusion coefficient (ADC) mapping
* Dynamic contrast-enhanced MRI (DCE-MRI) using a clinically approved contrast agent (Gadovist)
* T1/T2 mapping and other functional parameters (e.g., intravoxel incoherent motion, IVIM)

MRI scans will be performed at three standardized time points.

1. Pre-treatment: Within 14 days before TACE or SIRT.
2. Early Post-Treatment MRI: 24 hours after the intervention.
3. Follow-up MRI: four to six weeks after treatment for TACE / 3 months for SIRT.

All MRI examinations are conducted within the scope of clinical care. The study introduces no investigational drugs or additional procedures.

Inclusion criteria:

* Adults (≥18 years) with confirmed or suspected HCC who are eligible for TACE or SIRT.
* Scheduled for an MRI at defined time points as part of clinical care.
* Written informed consent

Exclusion criteria:

* General contraindications to MRI (e.g., pacemaker, metallic implants).
* Allergies or contraindications to gadolinium-based contrast agents
* Renal insufficiency (eGFR \<30 mL/min/1.73 m²)
* Pregnancy or breastfeeding.

Primary Objective:

Assess whether multiparametric MRI biomarkers correlate with histopathology, early response, and outcome after TACE or SIRT in patients with HCC.

Secondary objectives:

1. To evaluate the predictive value of mpMRI parameters regarding tumor response (e.g., mRECIST).
2. To assess the utility of mpMRI in guiding individualized therapy decisions.
3. To identify early imaging biomarkers for treatment stratification.

Imaging data and clinical outcomes will be pseudonymized and analyzed using pre-specified statistical methods. Image interpretation will be performed by experienced radiologists. This study adheres to the principles of the Declaration of Helsinki, the General Data Protection Regulation (GDPR), and Good Clinical Practice (GCP) standards, and has been approved by the local ethics committee.

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

Primary outcomes:
measure: Correlation of multiparametric MRI parameters with early therapy response
timeFrame: 4 to 6 weeks after TACE, 3 months after SIRT
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Clinic of Radiology, University of Münster
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.