2024-512490-27-00招募中2 期
Early detection of hepatocellular carcinoma by Hyperpolarized [1- 13C]pyruvate MRI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The raw data will be processed using both model-free and kinetic modeling approaches, which are the standards of analyzing hyperpolarized pyruvate MRI data, to quantify metabolism and perfusion.
研究概览
简要总结
This project seeks to determine the potential of hyperpolarized pyruvate MRI in early characterization of primary liver cancer - particularly small tumors.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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, 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.
排除标准
- •Chronic kidney disease
- •Contraindications for MRI with contrast:
- •Competing systemic disease (hypertension, dyslipidemia, diabetes etc. allowed)
- •Hepatic encephalopathy ≥ grade
- •Stents or other devices implanted close to the liver that may cause imaging artefacts
- •Allergy to pyruvate
- •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)
- •Largest circumference including arms > 160 cm
- •Claustrophobia
结局指标
主要结局
The raw data will be processed using both model-free and kinetic modeling approaches, which are the standards of analyzing hyperpolarized pyruvate MRI data, to quantify metabolism and perfusion.
The raw data will be processed using both model-free and kinetic modeling approaches, which are the standards of analyzing hyperpolarized pyruvate MRI data, to quantify metabolism and perfusion.
次要结局
未报告次要终点
研究者
Christoffer Laustsen
Scientific
Aarhus Universitet
研究点 (1)
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