GPC3-Targeted PET/CT in Hepatocellular Carcinoma

This study is designed to investigate GPC3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma. In this research, eligible patients will undergo contemporaneous GPC3-targeted PET/CT and contrast-enhanced liver MRI plus conventional extrahepatic imaging either for initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake will be quantified by the maximum standardized uptake value (SUVmax). Positive lesions detected by contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..

• GPC3-targeted PET/CT (Diagnostic test): Participants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.

Primary outcomes

• Diagnostic accuracy [1 year]: The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.

Secondary outcomes

• Agreement of BCLC classification with the reference classification [1 year]: The agreement of Barcelona Clinic Liver Cancer (BCLC) classification based on GPC3-targeted PET/CT with the reference BCLC classification will be assessed and compared with that based on conventional imaging, consisting of CE-MRI plus chest CT and other clinically indicated conventional imaging modalities. Unit of Measure: Proportion of patients with correct BCLC classification (%)
• Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT [Within 14 days]: In patients who undergo both examinations, the detection rates of reference-positive malignant lesions by GPC3-targeted PET/CT and 18F-FDG PET/CT will be calculated and compared, including hepatic lesions, metastatic lymph nodes, and distant metastases. Unit of Measure: Lesion detection rate (%)
• Gastric SUVmax Stratified by Gastric Filling Status [1 day]: Gastric filling status will be assessed on the low-dose CT component of PET/CT imaging and categorized according to the degree of gastric distension. Tracer uptake in the stomach will be quantified using SUVmax and SUVmean. Unit of Measure, SUVmax; SUVmean.

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

* Adult patients (aged 18 years or older);
* Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
* Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;

Exclusion Criteria:

* Lack of contrast-enhanced liver MRI or an interval of more than 14 days between GPC3-targeted PET/CT and contrast-enhanced liver MRI.
* Receipt of antitumor treatment between imaging examinations.
* The inability or unwillingness of the research participant or legal representative to provide written informed consent.
* Inability to complete PET/CT imaging.