GPC3-Targeted PET/CT in Hepatocellular Carcinoma

September 6, 2026 updated by: The First Affiliated Hospital of Xiamen University

Glypian-3 (GPC3)- Targeted PET Imaging 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 contrast-enhanced MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 contrast-enhanced liver MRI plus conventional extrahepatic imaging 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 contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GPC3-targeted PET/CT
Each subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time.
Diagnostic test: GPC3-targeted PET/CT
Participants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 1 year
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
Agreement of BCLC classification with the reference classification
Time Frame: 1 year

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 (%)
1 year
Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT
Time Frame: Within 14 days

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 (%)
Within 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMYY-2025KY019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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