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临床试验/NL-OMON36577
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.

Academisch Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新:
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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