Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT04626492
Eligibility Criteria:
Inclusion Criteria:
Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)
1. Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
2. no secondary portal hypertension and increase alpha feto protein(AFP);
3. no thrombus or plaque in the portal vein and abdominal aorta;
4. no history of psychotropic drug addiction;
5. MRI examination three days before liver puncture or liver transplantation;
6. isolated liver of patients undergoing liver transplantation.
The selection criteria of the normal control group (F0) (meet all the following 1-4 criteria can be selected or only meet the 5 criteria):
1. no known acute or chronic liver disease (serologically negative);
2. no history of alcoholism, and normal liver function tests;
3. no signs of chronic liver disease in CT or MRI;
4. no CT or MRI manifestations of focal or diffuse liver disease in the liver;
5. abandoned donor liver
Exclusion Criteria:
1. contraindications for MRI or patients' inability to cooperate with MRI;
2. allergy to contrast media and poor image quality can not meet the needs of clinical diagnosis;
3. less than 18 years of age, poor quality of liver biopsy;
4. renal insufficiency (eGFP \< 60ml/min/1.73mm2);
5. with severe heart, brain, lung and blood system diseases.
6. liver complicated with fulminant liver failure and gastrointestinal bleeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04626492
Study Brief:
Protocol Section:
NCT04626492