HepatomaNCT06700564
The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/CT and Enhanced MRI in Hepatic Malignancies
An observational study of Hepatoma, run by Shanghai East Hospital.
Trial summary
Liver disease is a major challenge for global public health, covering a wide range from mild liver dysfunction to serious diseases such as cirrhosis and liver cancer. Globally, the high incidence rate and mortality of liver diseases have led to a huge socio-economic burden, especially in developing countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatoma
- What is being tested?
- PET scan of FDG
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Nov 2027
- 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: patients with hepatocellular cancer
Who may be able to join
- Age ≥ 18 years old; Preliminary findings from other routine imaging examinations;
- Patients suspected of having liver metastasis or liver lesions, based on clinical symptoms and laboratory tests (such as alpha-fetoprotein levels);
- Preliminary findings from other routine imaging examinations;
- Able to perform 18F-FDG PET/MR examination and agree to follow the research procedure.
Who cannot join
- Patients with a history of allergy to MR contrast agents;
- Pregnant or lactating women;
- Patients with severe heart disease, renal failure, liver failure, etc;
- Patients who are unable to cooperate in completing PET/MR examinations.
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 is a major challenge for global public health, covering a wide range from mild liver dysfunction to serious diseases such as cirrhosis and liver cancer. Globally, the high incidence rate and mortality of liver diseases have led to a huge socio-economic burden, especially in developing countries. Primary liver cancer, especially hepatocellular carcinoma (HCC), is the fifth most common cancer and the third leading cause of cancer death worldwide. In addition, the liver is a common site of metastasis for various cancers, and the occurrence of liver metastasis significantly affects the prognosis and treatment strategies of patients. In this context, accurately diagnosing the nature of liver lesions has become the key to improving patient treatment outcomes. Distinguishing between benign and malignant liver lesions is crucial for avoiding unnecessary invasive interventions and ensuring timely and appropriate treatment. Similarly, timely identification of liver metastases is crucial for the overall management and improvement of survival rates in cancer patients.
Traditional imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) have been widely used for the detection and characterization of liver lesions, but they have limitations in diagnostic specificity and sensitivity, limited recognition of specific pathological features, and insufficient ability to detect small metastases. Positron emission tomography/computed tomography (PET/CT), as a widely used fusion imaging technique, combines the metabolic information of PET with the anatomical information of CT, demonstrating unique value in the diagnosis and treatment evaluation of various tumors. However, PET/CT has specific limitations in its application in liver diseases, especially in analyzing small liver lesions and distinguishing between benign and malignant tumors in the context of cirrhosis, which may be challenging. In addition, the radiation exposure caused by CT components is a significant issue that cannot be ignored in PET/CT examinations.
Relatively speaking, PET/MR combined with 18F-fluorodeoxyglucose (18F-FDG)provides a new diagnostic possibility, especially when used in conjunction with abdominal-enhanced MR on the same machine, which is expected to further improve diagnostic accuracy. However, despite the theoretical superiority of this technology over traditional methods, the actual degree of improvement, scope of application, and impact on clinical decision-making are still unclear. Therefore, despite high expectations for this technology, it is necessary to conduct a comprehensive study to evaluate the specific benefits of 18F-FDG PET/MR combined with abdominal-enhanced MR in the diagnosis of liver lesions, the particular degree of improvement in diagnostic accuracy, and its potential contribution to improving patient treatment outcomes. This not only helps to validate the practical application value of this technology in the diagnosis of liver lesions but also provides evidence for clinical doctors to optimize and personalize patient diagnosis and treatment plans. The results of this study will provide the scientific basis for future clinical practice, ensuring the effective and cost-effective application of this technology in the management of liver diseases.
Read the detailed description
This study is a prospective research design, enrolling 60 patients with suspected liver masses over a one-year period, who will undergo 18F-FDG PET/CT and enhanced MRI examinations.
- Conditions
- Hepatoma
- Being tested
- PET scan of FDG
- Keywords
- Hepatoma, pet/mr, contrast-enhanced MR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan of FDGOther
The enrolled patients will undergo PET examination, and the radiation dose generated during the examination will not cause physiological damage to the patients
| Study group | Role | What they receive |
|---|---|---|
| research group | This study adopts a prospective research design, with 60 patients suspected of having liver mass undergoing 18F-FDG PET/enhanced MR examination over one year. The inclusion criteria are as follows: age ≥ 18 years old; Patients suspected of having liver metastasis or liver lesions, based on clinical symptoms and laboratory tests (such as alpha-fetoprotein level); Preliminary findings from other routine imaging examinations; Able to perform 18F-FDG PET/MR examination and agree to follow the research procedure. The exclusion criteria are as follows: patients with a history of allergy to MR contrast agents; Pregnant or lactating women; Patients with severe heart disease, renal failure, liver failure, etc; Patients who are unable to cooperate in completing PET/MR examinations. This study passed the ethical review of Shanghai Oriental Hospital, and patients signed informed consent forms after enrollment. Receives: Other: PET scan of FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactive uptake
Assess the glucose uptake of the lesions.
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
manifestations of lesions on MR
Two physicians will collaboratively document the dimensions of liver lesions.
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
manifestations of lesions on MR
Two physicians will collaboratively assess the quantity of lesions.
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Signal characteristics on MRI
Evaluating the MR features of liver lesions, including T1 weighted, T2 weighted, diffusion-weighted imaging (DWI) characteristics, and enhanced features.
Measured: After the patient signs the informed consent form and 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 posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatomaStudies 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
- NCT06700564
- Sponsor's protocol ID
- 2024212
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to better protect patient privacy, the trial data will not be made public. Researchers can contact us via email to obtain the data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. 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/CT and Enhanced MRI in Hepatic Malignancies
- ClinicalTrials.gov ID
- NCT06700564
- Acronym / sponsor ID
- 2024212
- Conditions
- Hepatoma
- Keywords
- Hepatoma, pet/mr, contrast-enhanced MR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 22 Nov 2024 (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 is a major challenge for global public health, covering a wide range from mild liver dysfunction to serious diseases such as cirrhosis and liver cancer. Globally, the high incidence rate and mortality of liver diseases have led to a huge socio-economic burden, especially in developing countries. Primary liver cancer, especially hepatocellular carcinoma (HCC), is the fifth most common cancer and the third leading cause of cancer death worldwide. In addition, the liver is a common site of metastasis for various cancers, and the occurrence of liver metastasis significantly affects the prognosis and treatment strategies of patients. In this context, accurately diagnosing the nature of liver lesions has become the key to improving patient treatment outcomes. Distinguishing between benign and malignant liver lesions is crucial for avoiding unnecessary invasive interventions and ensuring timely and appropriate treatment. Similarly, timely identification of liver metastases is crucial for the overall management and improvement of survival rates in cancer patients.
Traditional imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) have been widely used for the detection and characterization of liver lesions, but they have limitations in diagnostic specificity and sensitivity, limited recognition of specific pathological features, and insufficient ability to detect small metastases. Positron emission tomography/computed tomography (PET/CT), as a widely used fusion imaging technique, combines the metabolic information of PET with the anatomical information of CT, demonstrating unique value in the diagnosis and treatment evaluation of various tumors. However, PET/CT has specific limitations in its application in liver diseases, especially in analyzing small liver lesions and distinguishing between benign and malignant tumors in the context of cirrhosis, which may be challenging. In addition, the radiation exposure caused by CT components is a significant issue that cannot be ignored in PET/CT examinations.
Relatively speaking, PET/MR combined with 18F-fluorodeoxyglucose (18F-FDG)provides a new diagnostic possibility, especially when used in conjunction with abdominal-enhanced MR on the same machine, which is expected to further improve diagnostic accuracy. However, despite the theoretical superiority of this technology over traditional methods, the actual degree of improvement, scope of application, and impact on clinical decision-making are still unclear. Therefore, despite high expectations for this technology, it is necessary to conduct a comprehensive study to evaluate the specific benefits of 18F-FDG PET/MR combined with abdominal-enhanced MR in the diagnosis of liver lesions, the particular degree of improvement in diagnostic accuracy, and its potential contribution to improving patient treatment outcomes. This not only helps to validate the practical application value of this technology in the diagnosis of liver lesions but also provides evidence for clinical doctors to optimize and personalize patient diagnosis and treatment plans. The results of this study will provide the scientific basis for future clinical practice, ensuring the effective and cost-effective application of this technology in the management of liver diseases.
Detailed description
This study is a prospective research design, enrolling 60 patients with suspected liver masses over a one-year period, who will undergo 18F-FDG PET/CT and enhanced MRI examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research group | – | Other: PET scan of FDGThis study adopts a prospective research design, with 60 patients suspected of having liver mass undergoing 18F-FDG PET/enhanced MR examination over one year. The inclusion criteria are as follows: age ≥ 18 years old; Patients suspected of having liver metastasis or liver lesions, based on clinical symptoms and laboratory tests (such as alpha-fetoprotein level); Preliminary findings from other routine imaging examinations; Able to perform 18F-FDG PET/MR examination and agree to follow the research procedure. The exclusion criteria are as follows: patients with a history of allergy to MR contrast agents; Pregnant or lactating women; Patients with severe heart disease, renal failure, liver failure, etc; Patients who are unable to cooperate in completing PET/MR examinations. This study passed the ethical review of Shanghai Oriental Hospital, and patients signed informed consent forms after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hepatocellular cancer
Key inclusion criteria (4 listed)
- Age ≥ 18 years old; Preliminary findings from other routine imaging examinations;
- Patients suspected of having liver metastasis or liver lesions, based on clinical symptoms and laboratory tests (such as alpha-fetoprotein levels);
- Preliminary findings from other routine imaging examinations;
- Able to perform 18F-FDG PET/MR examination and agree to follow the research procedure.
Key exclusion criteria (4 listed)
- Patients with a history of allergy to MR contrast agents;
- Pregnant or lactating women;
- Patients with severe heart disease, renal failure, liver failure, etc;
- Patients who are unable to cooperate in completing PET/MR examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan of FDGThe enrolled patients will undergo PET examination, and the radiation dose generated during the examination will not cause physiological damage to the patients | Other | research group |
Primary outcome
Radioactive uptake
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Assess the glucose uptake of the lesions.
manifestations of lesions on MR
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Two physicians will collaboratively document the dimensions of liver lesions.
manifestations of lesions on MR
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Two physicians will collaboratively assess the quantity of lesions.
Signal characteristics on MRI
Time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Evaluating the MR features of liver lesions, including T1 weighted, T2 weighted, diffusion-weighted imaging (DWI) characteristics, and enhanced features.
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 22 Nov 2024.
- Individual participant dataSharing planned: No. In order to better protect patient privacy, the trial data will not be made public. Researchers can contact us via email to obtain the data.
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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 Hepatoma, 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 22 Nov 2024. 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 (17810259215, dingjie940406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radioactive uptake (time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.). The study lists 4 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 22 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.