liver cirrhosis
Conditions
Interventions
Gold Standard:Gold standard: pathological examination of liver
Reference criteria: liver function and CT or MRI combined examination
Index test:Evaluation of liver function with aluminum fluoride labeled indocyanine green positron imaging agent in PET/CT
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with normal liver function 1) The subjects fully understand the content, process and possible adverse reactions of the test, have good compliance, voluntarily participate in the test and sign informed consent; 2) Age from 18 to 70 (including the threshold), no gender limitation; 3) Blood biochemical examination indicated normal Alt and/or ASpartate aminotransferase; 4) MRI and/or CT imaging examination showed no intrahepatic space-occupying lesions and cirrhosis; 5) No history of hepatitis; 6) No surgery or invasive treatment was performed; 2. Subjects with abnormal liver function 1) The subjects fully understand the content, process and possible adverse reactions of the test, have good compliance, voluntarily participate in the test and sign informed consent; 2) Age from 18 to 70 (including the threshold), no gender limitation; 3) Elevated alanine aminotransferase and/or aspartate aminotransferase were indicated by blood biochemical examination; 4) MRI and/or CT imaging findings suggest cirrhosis; 5) No surgery or invasive treatment was performed; 6) Patients scheduled for 18F-FDG PET/CT; 7) Patients who plan to undergo surgical treatment in our hospital.
Exclusion criteria
Exclusion criteria: 1. Subjects with normal liver function 1) People with allergies (such as previous allergies to two or more foods or drugs); 2) Patients with portal vein embolism, intrahepatic arteriovenous fistula, etc. may cause abnormal liver blood flow; (3) Oral or injection drugs may affect liver function practitioners; 4) patients with untreated or uncontrolled hypertension (systolic blood pressure > 150mmHg and/or diastolic blood pressure > 100mmHg); 5) patients clinically diagnosed as renal insufficiency; 6) Patients with an expected survival of less than 6 months; 7) Patients with abnormal heart function that the investigator considers unsuitable for clinical trial; 8) have a clinically active, serious, uncontrollable systemic disease (e.g., dyspnea, acute episode of asthma, etc.) that, in the investigator's judgment, would affect the subjects' participation in/completion of the study or the evaluation of liver function. 2. Subjects with abnormal liver function 1) People with allergies (such as previous allergies to two or more foods or drugs); 2) Patients with portal vein embolism, intrahepatic arteriovenous fistula, etc. may cause abnormal liver blood flow; 3) Biliary cirrhosis, obstructive jaundice, and cholestatic liver disease may lead to impaired bile secretion The lender; 4) have untreated or uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100 MMHG); 5) Patients with significant changes in liver reserve function during clinical diagnostic tests (such as patients with acute viral hepatitis in pre-jaundice and jaundice stage, etc.); 6) patients clinically diagnosed as renal insufficiency; 7) Patients with hepatic encephalopathy grade ? or above; 8) Patients with an expected survival of less than 6 months; 9) Patients with abnormal heart function that the investigator considers unsuitable for clinical trials; 10) patients with clinically active, serious and uncontrollable systemic diseases (e.g., dyspnea, acute asthmatic episodes, etc.) that, in the investigator's judgment, would affect the subjects' participation in/completion of the study, or affect the evaluation of liver function; 11) Suffering from psychological or social disorders that may interfere with participation in research or evaluation of research results, or having a history of substance abuse; 12) Those who received gallbladder contrast agents, rifampicin, anti-gout agents (such as colchicine, allopurine and Traditional Chinese medicine, etc.), cholagic agents (such as ursodeoxycholic acid, phenylpropanol and traditional Chinese medicine, etc.), which were judged by researchers to affect liver function evaluation; 13) Patients with immune diseases undergoing hormone therapy; 14) Those who have used contrast media of thyroid hormone, steroid hormone or other fluorine-containing drugs within 7 days before receiving the test drugs; 15) Those who suffer from claustrophobia or cannot tolerate lying flat for at least 30 minutes, or cannot tolerate imaging tests; 16) Female subjects who plan to have children in the next 3 months, or who are pregnant or breastfeeding; 17) Those who have participated in any drug clinical trial or device clinical trial within 3 months prior to accepting the test drug, and have used the test drug or device; 18) Subjects may not be able to complete the study for other reasons, or the investigator considers that they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of liver clearance; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of liver uptake;Blood clearance rate; | — |
Countries
China
Contacts
Public ContactZhang Jinming
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed