About this trial
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with 18F-FDG PET/CT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
The inability or unwillingness of the research participant or legal representative to provide written informed consent.
Inability to complete PET/CT imaging.
Trial design
Single group
Treatments tested in this trial
18F-FDG PET/CT and GPC3-targeted PET/CT
Diagnostic testParticipants will receive a single intravenous injection of 18F-FDG and 68Ga-GPC3, and undergo PET/CT imaging within the specified time.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 18F-FDG PET/CT and GPC3-targeted PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Secondary outcomes
Gastric SUVmax Stratified by Gastric Filling Status
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.
Sponsors and contacts
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