Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07050550

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-07-03

45

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

N

National Natural Science Foundation of China

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 80 years old
  • Clinically diagnosed with liver damage shown by changes in liver enzymes, abnormal bilirubin metabolism, and impaired liver functions
  • Clinically diagnosed with liver failure characterized by severe liver dysfunction and symptoms such as jaundice, coagulation problems, or hepatic encephalopathy
  • Able to give informed consent, willing to comply with study requirements and follow-up
Not Eligible

You will not qualify if you...

  • Serious primary diseases of the heart, brain, kidney, or blood system (e.g., severe heart failure, low blood counts, low kidney function)
  • Mental disorders or primary affective disorders
  • Unable to understand the study protocol or sign informed consent
  • Contraindications to PET imaging, including pregnancy, breastfeeding, or plans for pregnancy
  • Allergies to imaging agents
  • Unable to cooperate with PET scanning due to hypoglycemia, severe pain, or tremor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 6 months

Participants undergo 18F-DFA PET imaging to assess liver function injury and correlate with clinical biochemical liver function indicators or liver puncture pathological results.

1 PET scan visit with a 10-minute scan followed by a 1-hour wait in the examination room before leaving

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

Hangzhou, Zhejiang, China, 310006

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Research Team

Q

QINGQING HU, DOCTOR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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