A Prospective Study of ¹⁸F-DFA PET Imaging for the Assessment of Liver Injury

ConditionLiver Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This study is a prospective exploratory clinical study aimed at evaluating the efficacy (sensitivity, specificity) of 18F-DFA PET imaging in assessing liver function damage. Subjects who meet the inclusion criteria are screened and enter this study to receive 18F-DFA PET imaging assessment, with clinical biochemical liver function indicators or liver puncture pathological examination as controls.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Aged between 18 and 80 years old; 2) Clinically diagnosed with liver damage (combined with medical history and laboratory tests, manifested as changes in liver enzymes, abnormal bilirubin metabolism, dysfunction of substance synthesis, and decreased biodegradation function, including indicators such as ALT, AST, ALP, GGT, albumin (Alb), TBil, and DBil); 3) Clinically diagnosed with liver failure (liver failure is a severe liver damage caused by multiple factors, resulting in severe dysfunction or decompensation of its synthesis, detoxification, excretion, and biotransformation functions, and a group of clinical syndromes with coagulation dysfunction, jaundice, hepatic encephalopathy, ascites, etc. as the main manifestations. Key points for the diagnosis of liver failure (a) Extreme fatigue, and severe gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension; (b) Progressive deepening of jaundice (serum TBil ≥171μmol/L or daily increase ≥17.1μmol/L); (c) Bleeding tendency, plasma prothrombin activity (PTA≤40% or international normalized ratio (INR ≥ 1.5; (d) hepatic encephalopathy (grade II or above) or other complications.); 4) informed consent and able to accept follow-up, can understand and comply with the requirements of the study

Disqualifiers

1) Patients with serious primary diseases of the heart, brain, kidney and hematopoietic system (i.e. Weber heart function grade D; hemoglobin (Hb) <10 g/dL, white blood cells (WBC) <3×109/L, platelets (PLT) <90×109/L; creatinine clearance (CrCl) <40 mL/min); 2) Patients with mental disorders or primary affective disorders; 3) Patients who cannot understand, follow the study protocol or sign the informed consent form; 4) Patients with contraindications to PET imaging (including pregnant women, breastfeeding women, women of childbearing age who have plans to have children in the near future, etc.); 5) Patients with allergies to imaging agents; 6) Patients who cannot cooperate with PET scanning due to hypoglycemia, severe pain or tremor.

Trial population

1. Clinical diagnosis of liver damage (combined with medical history and laboratory tests, manifested as changes in liver enzymes, abnormal bilirubin metabolism, dysfunction of substance synthesis and decreased biodegradation function, including indicators such as ALT, AST, ALP, GGT, albumin (Alb), TBil and DBil); 2. Clinical diagnosis of liver failure (liver failure is a severe liver damage caused by multiple factors, resulting in severe dysfunction or decompensation of its synthesis, detoxification, excretion and biotransformation functions, and a group of clinical syndromes with coagulation dysfunction, jaundice, hepatic encephalopathy, ascites as the main manifestations. Key points for the diagnosis of liver failure (a) Extreme fatigue, and severe gastrointestinal symptoms such as obvious anorexia, vomiting and abdominal distension; (b) Progressive deepening of jaundice (serum TBil ≥171μmol/L or daily increase ≥17.1μmol/L); (c) Bleeding tendency, plasma prothrombin activity (PTA≤40

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

45 Participants
are grouped into 1 trial group
Group A: liver injury

Trial outcomes

Primary outcomes

1

Change from Baseline in the MAX%ID SUV in PET-CT imaging at 6 Months

Change from Baseline in the MAX%ID SUV in PET-CT imaging at 6 Months

Time frame
The scan takes 10 minutes. After the scan is completed, patients will wait in the examination room for 1 hour before returning.
2

To evaluate the correlation between liver uptake of 18F-DFA and liver function injury indicators (clinical biochemical liver function indicators or liver puncture pathological results).

To evaluate the correlation between liver uptake of 18F-DFA and liver function injury indicators (clinical biochemical liver function indicators or liver puncture pathological results).

Time frame
The scan takes 10 minutes. After the scan is completed, patients will wait in the examination room for 1 hour before returning.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

National Natural Science Foundation of China

Collaborator