Liver Cancer, AdultNCT07055048
The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/Contrast-enhanced MRI in Malignant Liver Lesions
An observational study of Liver Cancer, Adult, run by Shanghai East Hospital.
Trial summary
Liver disease, a major global health burden, ranges from mild dysfunction to severe conditions like cirrhosis and hepatocellular carcinoma (HCC), the fifth most common cancer. Accurate diagnosis of liver lesions-distinguishing benign from malignant-is vital for treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Who may be able to join
- Age ≥18 years;
- Patients with suspected liver metastases or hepatic lesions,
- Ability to undergo 18F-FDG PET/MRI examination;
- Willingness to comply with study protocols.
Who cannot join
- Patients with a history of allergic reactions to MRI contrast agents;
- Pregnant or lactating women;
- Patients with severe comorbidities, including: Cardiac disease，Renal failure，or Hepatic failure (Child-Pugh C);
- Patients unable to cooperate with PET/MRI procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Liver disease, a major global health burden, ranges from mild dysfunction to severe conditions like cirrhosis and hepatocellular carcinoma (HCC), the fifth most common cancer. Accurate diagnosis of liver lesions-distinguishing benign from malignant-is vital for treatment planning. Conventional imaging (ultrasound, CT, MRI) has limitations in sensitivity and detecting small metastases. PET/CT combines metabolic and anatomical data but struggles with small lesions and cirrhotic livers.
18F-FDG PET/MRI with contrast-enhanced MRI may improve diagnostic accuracy, but its clinical benefits remain uncertain. Further research is needed to evaluate its performance, impact on patient outcomes, and cost-effectiveness in liver disease management.
Read the detailed description
Liver disease is a major global public health challenge, ranging from mild dysfunction to severe conditions like cirrhosis and liver cancer. The high morbidity and mortality of liver diseases impose a significant socioeconomic burden, especially in developing countries. Primary liver cancer, particularly hepatocellular carcinoma (HCC), ranks as the fifth most common cancer and the third leading cause of cancer-related deaths worldwide. Additionally, the liver is a frequent site for metastases, and their presence critically impacts patient prognosis and treatment strategies.
Accurate diagnosis of liver lesions is essential for improving patient outcomes. Distinguishing benign from malignant lesions helps avoid unnecessary invasive procedures and ensures timely treatment. Similarly, early detection of liver metastases is crucial for cancer management and survival.
Conventional imaging techniques-such as ultrasound, CT, and MRI-are widely used for liver lesion assessment but have limitations, including insufficient specificity/sensitivity and difficulty in detecting small metastases. PET/CT, combining metabolic and anatomical data, is valuable in oncology but has drawbacks in liver applications, such as limited resolution for small lesions and challenges in differentiating malignancies in cirrhotic livers. Radiation exposure from CT is another concern.
In contrast, 18F-FDG PET/MRI with contrast-enhanced abdominal MRI offers a promising alternative, potentially improving diagnostic accuracy. However, despite its theoretical advantages, the actual clinical benefits remain unclear. A comprehensive study is needed to evaluate its diagnostic performance, accuracy, and impact on patient outcomes. Such research would validate its clinical utility, guide optimized treatment strategies, and ensure cost-effective integration into liver disease management.
- Conditions
- Liver Cancer, Adult
- Keywords
- PET/MR, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
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 |
|---|---|---|
| Research group | It is expected to include 60 patients with suspected hepatic space-occupying lesions , and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic parameters
For all liver lesions, the maximum standardized uptake value (SUVmax) will be calculated.
Measured: After the patient completes the scan, an average of 2 days.
MRI enhancement pattern
The MRI protocol will specifically evaluate the dynamic contrast-enhanced patterns of lesions, including their enhancement characteristics during the arterial phase, portal venous phase, and delayed phase.
Measured: After the patient completes the scan, an average of 2 days.
Normal liver SUVmax
Calculate the maximum standardized uptake value (SUVmax) of normal liver tissue surrounding the lesion.
Measured: After the patient completes the scan, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 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 Cancer, AdultStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055048
- Sponsor's protocol ID
- 2024YS-212
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/Contrast-enhanced MRI in Malignant Liver Lesions
- ClinicalTrials.gov ID
- NCT07055048
- Acronym / sponsor ID
- 2024YS-212
- Conditions
- Liver Cancer, Adult
- Keywords
- PET/MR, liver cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 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.
Liver disease, a major global health burden, ranges from mild dysfunction to severe conditions like cirrhosis and hepatocellular carcinoma (HCC), the fifth most common cancer. Accurate diagnosis of liver lesions-distinguishing benign from malignant-is vital for treatment planning. Conventional imaging (ultrasound, CT, MRI) has limitations in sensitivity and detecting small metastases. PET/CT combines metabolic and anatomical data but struggles with small lesions and cirrhotic livers.
18F-FDG PET/MRI with contrast-enhanced MRI may improve diagnostic accuracy, but its clinical benefits remain uncertain. Further research is needed to evaluate its performance, impact on patient outcomes, and cost-effectiveness in liver disease management.
Detailed description
Liver disease is a major global public health challenge, ranging from mild dysfunction to severe conditions like cirrhosis and liver cancer. The high morbidity and mortality of liver diseases impose a significant socioeconomic burden, especially in developing countries. Primary liver cancer, particularly hepatocellular carcinoma (HCC), ranks as the fifth most common cancer and the third leading cause of cancer-related deaths worldwide. Additionally, the liver is a frequent site for metastases, and their presence critically impacts patient prognosis and treatment strategies.
Accurate diagnosis of liver lesions is essential for improving patient outcomes. Distinguishing benign from malignant lesions helps avoid unnecessary invasive procedures and ensures timely treatment. Similarly, early detection of liver metastases is crucial for cancer management and survival.
Conventional imaging techniques-such as ultrasound, CT, and MRI-are widely used for liver lesion assessment but have limitations, including insufficient specificity/sensitivity and difficulty in detecting small metastases. PET/CT, combining metabolic and anatomical data, is valuable in oncology but has drawbacks in liver applications, such as limited resolution for small lesions and challenges in differentiating malignancies in cirrhotic livers. Radiation exposure from CT is another concern.
In contrast, 18F-FDG PET/MRI with contrast-enhanced abdominal MRI offers a promising alternative, potentially improving diagnostic accuracy. However, despite its theoretical advantages, the actual clinical benefits remain unclear. A comprehensive study is needed to evaluate its diagnostic performance, accuracy, and impact on patient outcomes. Such research would validate its clinical utility, guide optimized treatment strategies, and ensure cost-effective integration into liver disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | – | –It is expected to include 60 patients with suspected hepatic space-occupying lesions , and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Patients with suspected liver metastases or hepatic lesions,
- Ability to undergo 18F-FDG PET/MRI examination;
- Willingness to comply with study protocols.
Key exclusion criteria (4 listed)
- Patients with a history of allergic reactions to MRI contrast agents;
- Pregnant or lactating women;
- Patients with severe comorbidities, including: Cardiac disease，Renal failure，or Hepatic failure (Child-Pugh C);
- Patients unable to cooperate with PET/MRI procedures.
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
Metabolic parameters
Time frame: After the patient completes the scan, an average of 2 days.
For all liver lesions, the maximum standardized uptake value (SUVmax) will be calculated.
MRI enhancement pattern
Time frame: After the patient completes the scan, an average of 2 days.
The MRI protocol will specifically evaluate the dynamic contrast-enhanced patterns of lesions, including their enhancement characteristics during the arterial phase, portal venous phase, and delayed phase.
Normal liver SUVmax
Time frame: After the patient completes the scan, an average of 2 days.
Calculate the maximum standardized uptake value (SUVmax) of normal liver tissue surrounding the lesion.
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 8 Jul 2025.
- Individual participant dataSharing planned: No. For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, Adult, run by Shanghai East Hospital.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Ding, MD (086-38804518, dingjie940406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic parameters (time frame: After the patient completes the scan, an average of 2 days.). The study lists 3 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 8 Jul 2025.