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NCT06700564Not yet recruiting

The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/CT and Enhanced MRI in Hepatic Malignancies

Source: ClinicalTrials.gov · Last updated 22 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
22 Oct 2024
Start date
1 Dec 2024
Primary completion date
30 Nov 2027
Lead sponsor
Shanghai East Hospital
NCT number
NCT06700564

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 1 Dec 2024 to the primary completion date, 30 Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with a history of allergy to MR contrast agents;
  • Patients with severe heart disease, renal failure, liver failure, etc;

Other

  • Pregnant or lactating women;
  • Patients who are unable to cooperate in completing PET/MR examinations.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.