NL-OMON36577撤回不适用
Assessment of Choline levels in focal nodular hyperplasia (FNH), hepatocellular adenoma (HCA), and hepatocellular carcinoma (HCC) using proton Magnetic Resonance Spectroscopy. - Choline levels in livertumors.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Affirmed diagnosis of FNH, HCA or HCC based on:
- •- Histopathological proof
- •- If no histological proof was obtained: results of imaging modalities characteristic for FNH, HCA or HCC. These characteristics of MR and CT imaging include:
- •* HCA: Hypervascular lesion in the arterial phase and signs of bleeding and/or fat within the lesion.
- •* FNH: Hypervascular lesion in the arterial phase, and the presence of a central scar.
- •* HCC: Hypervascular lesion in the arterial phase, followed by wash-out during the portal or late phase AND positive patient history for risk factors in HCC development including hepatitis B and C, haemochromatosis, alcohol abuses and cirrhosis OR elevated alpha fetoprotein 1.
- •2. Size of the lesion: > 2 cm.
- •3. 18 years of age or older.
- •4. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •1. Contraindications for MR imaging:
- •- Pacemaker, medicine pump, neurostimulator, claustrophobia, iron slivers in the eye, brace.
- •- Irremovable body piercing, iron particles in the body.
- •- Patients with extreme obesity (will not fit in the bore of the MRI)
研究者
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