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| ID | Type | Description | Link |
|---|---|---|---|
| University of Münster | Other Grant/Funding Number | 2025-207-f-S |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC patients undergoing TACE or SIRT | Patients with hepatocellular carcinoma scheduled for TACE or SIRT, undergoing multiparametric MRI at three defined time points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Max Masthoff, MD | Contact | +492518343018 | max.masthoff@ukmuenster.de | |
| Philipp Schindler, MD | Contact | +492518343015 | philipp.schindler@ukmuenster.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Radiology, University of Münster | Recruiting | Münster | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38580362 | Background | 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. | |
| 36589457 | 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. |
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Individual participant data will not be shared for this study. The study is observational and does not include consent for data sharing beyond internal analysis.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 38641651 | 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D003933 | Diagnosis |