on-invasive rapid assessment of non-alcoholic fatty liver disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL) - RADIcAL 1 study

Perspectum Diagnostics0 个研究点目标入组 177 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

Trial is onging in other countries

•* Male and female patients aged 18-75, due to undergo evaluation for suspected
•non-alcoholic fatty liver disease
•* Participant is willing and able to give informed consent for participation in
•* Within standard of care presence of:
•- elevated liver function tests (ALT, AST or GGT * 1.5 x upper limit of normal
•and ALT, AST * 5 x upper limit of normal) up to 1 year prior to patient
•recruitment
•- imaging suggestive of Fatty liver disease up to 3 years prior to patient
•recruitment OR
•Presence of * 3 of the following criteria at screening::
•1) insulin resistance or type 2 diabetes mellitus
•2) obesity (BMI > 30 or waist-to-hip ratio > 1.00 for men / > 0.85 for women)
•3) hypertension (* 130/85 mmHg)
•4) elevated triglycerides (* 1.7 mmol/l)
•5) low HDL-cholesterol (< 1.05 mmol/l for men / < 1.25 mmol/l for women)

•* The participant may not enter the study if they have any contraindication to
•magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker,
•shrapnel injury, severe claustrophobia).
•* Patients with proven liver disease other than NAFLD.
•* Liver transplantation
•* Patients that present with clinical signs of chronic liver failure (variceal
•bleeding, ascites, overt encephalopathy)
•* Pregnancy
•* Alcohol over-use/ abuse as determined by local guidelines
•* Patient with known malignant liver tumours and those with any malignancy with
•life expectancy < 36 months
•* Heart failure NYHA stages II-IV

发起方