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NCT Number: NCT07677774

GPC3-Targeted PET/CT in Hepatocellular Carcinoma

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 18F-FDG 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 18F-FDG PET/CT and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or with contrast-enhanced MRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • The inability or unwillingness of the research participant or legal representative to provide written informed consent.
  • Inability to complete PET/CT imaging.

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 1 year

    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

  1. Gastric SUVmax Stratified by Gastric Filling Status

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haojun Chen

CONTACT

[email protected]

86 18659285282

Liang Zhao

CONTACT

[email protected]

86 18818350620

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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