NCT07050550 A Prospective Study of ¹⁸F-DFA PET Imaging for the Assessment of Liver Injury
| NCT ID | NCT07050550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2024-12-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Xiaowei XU, DOCTOR
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT07050550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07050550 currently recruiting?
Yes, NCT07050550 is actively recruiting participants. Contact the research team at ivyhu@zju.edu.cn for enrollment information.
Where is the NCT07050550 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07050550 clinical trial?
NCT07050550 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Xiaowei XU, DOCTOR at Zhejiang University. The trial plans to enroll 45 participants.