Multiparametric MRI for Optimized Imaging-based Characterization and Therapy Management of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Correlation of multiparametric MRI parameters with early therapy response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Correlation of multiparametric MRI parameters with early therapy response
时间窗: 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
次要结局
未报告次要终点
研究者
Emily Hoffmann
MD
University Hospital Muenster