18F‑DFA PET scan to visualize liver damage
A Prospective Study of ¹⁸F-DFA PET Imaging for the Assessment of Liver Injury
This study will test whether 18F‑DFA PET scans can show liver damage in adults with liver injury compared with blood tests or biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07050550 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with clinically diagnosed liver injury or liver failure based on history and laboratory tests are ideal candidates.
Not a fit: People without clinical evidence of liver injury or those unable to undergo PET imaging (for example because of pregnancy or inability to tolerate scanning) are unlikely to benefit.
Why it matters
Potential benefit: If successful, the PET scan could provide a noninvasive way to detect and map liver damage across the whole liver, potentially reducing the need for repeated biopsies.
How similar studies have performed: Other PET tracers have been applied to liver pathology with some encouraging results, but 18F‑DFA is a novel tracer with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.