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
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