Liver InjuryNCT07050550
A Prospective Study of ¹⁸F-DFA PET Imaging for the Assessment of Liver Injury
An observational study of Liver Injury, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Injury
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, 310006
About this study
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.
Read the detailed description
Liver injury (LI) refers to a clinical syndrome caused by a rapid decline in liver function due to various causes in a short period of time, manifested by increased transaminase and bilirubin, pain in the liver area, abdominal distension, and jaundice. Acute treatment should be systematically carried out because liver injury can lead to liver dysfunction and even liver failure, and severe liver necrosis, which is life-threatening.
Currently, peripheral blood biochemistry, ultrasound, CT, MR, and liver biopsy are routinely used in clinical practice to evaluate the physiological and pathological changes of the liver during liver injury. The assessment of liver function from plasma is indirect, and marker molecules such as transaminases are diluted in the entire blood volume. During liver failure, when various processes such as inflammatory storms occur simultaneously, the results will be disturbed. Among the above methods, liver biopsy is the gold standard. However, liver biopsy only samples 1/50,000 to 1/100,000 of the liver, resulting in significant sampling errors. This heterogeneity of the liver is particularly significant when liver disease is heterogeneous, such as during liver injury and liver failure. Therefore, it is particularly important to find a non-invasive visualization that can display liver damage and liver failure in real time.
Vitamin C (VC), also known as L-ascorbic acid, is an essential water-soluble vitamin for the human body. As part of antioxidant and carbohydrate metabolism, VC participates in the circulation between liver cells and organs, mainly involving the hexuronic acid pathway, pentose phosphate cycle, glycolysis and gluconeogenesis. Glycogenolysis, as the main source of UDP-glucuronic acid, determines the rate of the hexuronic acid pathway leading to ascorbic acid synthesis. Glycogenolysis is regulated by oxidized and reduced glutathione. Therefore, glycogen, ascorbic acid and glutathione metabolism are interrelated, and the three together affect the antioxidant status of the liver. 6-Deoxy-6-[18F]fluoro-L-ascorbic acid (18F-DFA) is a radioactive tracer for positron emission tomography (PET) based on the structure of natural ascorbic acid (vitamin C). Recent literature reports show that 18F-DFA PET imaging can be used to evaluate liver damage and liver failure caused by acetaminophen. It can be seen that 18F-DFA PET molecular imaging is a promising diagnostic method for acute liver function injury, which may have higher sensitivity and specificity for the diagnosis of liver function injury and the evaluation of therapeutic efficacy.
In order to further observe the clinical diagnostic effect of this imaging method, we designed this prospective exploratory clinical study to further determine the effectiveness and safety of 18F-DFA PET imaging in evaluating liver function injury. Study purpose: To evaluate the efficacy (sensitivity, specificity) of 18F-DFA PET imaging in evaluating liver function injury with clinical biochemical liver function indicators or liver puncture pathological examination as control. 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).
- Conditions
- Liver Injury
- Keywords
- liver injury, pet-ct, 18F-DFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver injury | liver injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: The scan takes 10 minutes. After the scan is completed, patients will wait in the examination room for 1 hour before returning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Dec 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Xiaowei XU, DOCTOR, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050550
- Sponsor's protocol ID
- 3.0
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, we will compile all the data into an article and publish it, including the imaging and clinical data of all patients.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of ¹⁸F-DFA PET Imaging for the Assessment of Liver Injury
- ClinicalTrials.gov ID
- NCT07050550
- Acronym / sponsor ID
- 3.0
- Conditions
- Liver Injury
- Keywords
- liver injury, pet-ct, 18F-DFA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Liver injury (LI) refers to a clinical syndrome caused by a rapid decline in liver function due to various causes in a short period of time, manifested by increased transaminase and bilirubin, pain in the liver area, abdominal distension, and jaundice. Acute treatment should be systematically carried out because liver injury can lead to liver dysfunction and even liver failure, and severe liver necrosis, which is life-threatening.
Currently, peripheral blood biochemistry, ultrasound, CT, MR, and liver biopsy are routinely used in clinical practice to evaluate the physiological and pathological changes of the liver during liver injury. The assessment of liver function from plasma is indirect, and marker molecules such as transaminases are diluted in the entire blood volume. During liver failure, when various processes such as inflammatory storms occur simultaneously, the results will be disturbed. Among the above methods, liver biopsy is the gold standard. However, liver biopsy only samples 1/50,000 to 1/100,000 of the liver, resulting in significant sampling errors. This heterogeneity of the liver is particularly significant when liver disease is heterogeneous, such as during liver injury and liver failure. Therefore, it is particularly important to find a non-invasive visualization that can display liver damage and liver failure in real time.
Vitamin C (VC), also known as L-ascorbic acid, is an essential water-soluble vitamin for the human body. As part of antioxidant and carbohydrate metabolism, VC participates in the circulation between liver cells and organs, mainly involving the hexuronic acid pathway, pentose phosphate cycle, glycolysis and gluconeogenesis. Glycogenolysis, as the main source of UDP-glucuronic acid, determines the rate of the hexuronic acid pathway leading to ascorbic acid synthesis. Glycogenolysis is regulated by oxidized and reduced glutathione. Therefore, glycogen, ascorbic acid and glutathione metabolism are interrelated, and the three together affect the antioxidant status of the liver. 6-Deoxy-6-[18F]fluoro-L-ascorbic acid (18F-DFA) is a radioactive tracer for positron emission tomography (PET) based on the structure of natural ascorbic acid (vitamin C). Recent literature reports show that 18F-DFA PET imaging can be used to evaluate liver damage and liver failure caused by acetaminophen. It can be seen that 18F-DFA PET molecular imaging is a promising diagnostic method for acute liver function injury, which may have higher sensitivity and specificity for the diagnosis of liver function injury and the evaluation of therapeutic efficacy.
In order to further observe the clinical diagnostic effect of this imaging method, we designed this prospective exploratory clinical study to further determine the effectiveness and safety of 18F-DFA PET imaging in evaluating liver function injury. Study purpose: To evaluate the efficacy (sensitivity, specificity) of 18F-DFA PET imaging in evaluating liver function injury with clinical biochemical liver function indicators or liver puncture pathological examination as control. 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver injury | – | –liver injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in the MAX%ID SUV in PET-CT imaging at 6 Months
Time frame: The scan takes 10 minutes. After the scan is completed, patients will wait in the examination room for 1 hour before returning.
Change from Baseline in the MAX%ID SUV in PET-CT imaging at 6 Months
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).
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. After the study is completed, we will compile all the data into an article and publish it, including the imaging and clinical data of all patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaowei XU, DOCTOR principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Injury, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QINGQING HU, DOCTOR (+8617799853795, ivyhu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the MAX%ID SUV in PET-CT imaging at 6 Months (time frame: The scan takes 10 minutes. After the scan is completed, patients will wait in the examination room for 1 hour before returning.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.