18F‑DFA PET scan to visualize liver damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective exploratory imaging study enrolling adults with clinically diagnosed liver injury or liver failure. Enrolled participants will undergo 18F‑DFA PET imaging and results will be compared with standard biochemical liver function tests and liver biopsy/pathology when available. The study will calculate sensitivity and specificity of the PET imaging for detecting liver damage. The aim is to determine whether 18F‑DFA PET can provide a noninvasive, real-time map of heterogeneous liver injury.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Xiaowei XU, DOCTOR — Zhejiang University
• Study coordinator: Qingqing Hu, Doctor
• Email: ivyhu@zju.edu.cn
• Phone: +8617799853795

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.