GPC3-Targeted PET/CT in Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
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 18F-FDG PET/CT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 18F-FDG PET/CT and GPC3-targeted PET/CT

    Diagnostic test

    Participants will receive a single intravenous injection of 18F-FDG and 68Ga-GPC3, and undergo PET/CT imaging within the specified time.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: GPC3-targeted PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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 day

Other outcomes

Sponsors and contacts

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