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

NCT07050550 | Recruiting

• 1 other identifier: 3.0
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Injury

Keywords

liver injury; pet-ct; 18F-DFA

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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).

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

Study Arms (1)

liver injury

liver injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• The National Natural Science Foundation of China (NSFC): collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310006, China

RECRUITING

Study Officials

• Xiaowei XU, DOCTOR

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

QINGQING HU, DOCTOR

CONTACT

+8617799853795; ivyhu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 3, 2025
• Study Start: December 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 1 year after publication with no end date

Locations

CN (1)