GPC3-Targeted PET/CT in Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe First Affiliated Hospital of Xiamen University
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 contrast-enhanced MRI.
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
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.
Trial design
Design model
Single group
Treatments tested in this trial
GPC3-targeted PET/CT
Diagnostic testParticipants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: GPC3-targeted PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
Time frame
1 yearSecondary outcomes
1
Agreement of BCLC classification with the reference classification
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 (%)
Time frame
1 year2
Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT
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 (%)
Time frame
Within 14 days3
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.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov