GPC3-Targeted PET/CT in Hepatocellular Carcinoma
Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
September 10, 2026
May 1, 2026
1.1 years
June 8, 2026
September 6, 2026
Conditions
Keywords
Outcome Measures
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.
1 year
Secondary Outcomes (3)
Agreement of BCLC classification with the reference classification
1 year
Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT
Within 14 days
Gastric SUVmax Stratified by Gastric Filling Status
1 day
Study Arms (1)
GPC3-targeted PET/CT
EXPERIMENTALEach subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time.
Interventions
Participants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
July 1, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
September 10, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share