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Recruiting NCT07677774

GPC3-Targeted PET/CT in Hepatocellular Carcinoma

No phase Interventional Hepatocellular Carcinoma (HCC) Glypican-3 GPC3-targeted PET/CT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-FDG PET/CT and GPC3-targeted PET/CT.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC), Glypican-3, GPC3-targeted PET/CT. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Diagnostic efficacy [Time frame: 1 year]
Secondary outcome measures (1)
  • Gastric SUVmax Stratified by Gastric Filling Status [Time frame: 1 day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT07677774 · XMYY-2025KY019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗