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临床试验/EUCTR2021-000863-56-DK
EUCTR2021-000863-56-DK进行中(未招募)1 期

Early detection of hepatocellular carcinoma by Hyperpolarized [1-13C]pyruvate MRI

Aarhus University, The MR Research Center0 个研究点目标入组 46 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
46

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • All participants:
  • -Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the participating patients.
  • -Pre-menopausal women must be confirmed non-pregnant by an onsite test
  • HCC group:
  • -Diagnosed HCC larger than 10 mm confirmed by standard MRI, or CT or confirmed by tumour biopsy.
  • -Subgroup 1: Not elected for liver surgery
  • -Subgroup 2: Elected for liver surgery
  • Small tumor group:
  • -One or more small lesions in the liver requiring 2 years of repeated follow-up as per the EASL guideline. Could be in a liver with a confirmed HCC.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 16

排除标准

  • Contraindications for MRI with contrast:
  • -Chronic kidney disease
  • -Patients with tumors must have eGFR > 30 ml/min/1.73m2
  • -Significant cardiac disease (as left ventricular outflow obstruction or heart failure)
  • -Significant obstructive lung disease or severe asthma
  • -Pacemaker, neurostimulator or cholera implant
  • -Metal foreign bodies such as fragments and irremovable piercings
  • -Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
  • -Claustrophobia
  • -Largest circumference including arms > 160 cm
  • Competing systemic disease including diabetes (hypertension, dyslipidemia, diabetes etc. allowed)
  • Hepatic encephalopathy = grade 2.
  • Stents or other devices implanted close to the liver that may cause imaging artefacts
  • Allergy to pyruvate

研究者

发起方
Aarhus University, The MR Research Center

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