Multiparametric MRI for Characterization of Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-05-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC patients undergoing TACE or SIRT

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

Multiparametric MRI

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No