Clinical trial · Interventional
Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Liver | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-aGPC3-scFv/Fab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET imaging targeting GPC3 in hepatocellular carcinoma
- description
- Determine if targeting GPC3 PET is safe and effective method for imaging of hepatocellular carcinoma
- interventionNames
- Drug: 68Ga-aGPC3-scFv/Fab
Primary outcomes (1)
- measure
- Visual and standardized uptake values assessment of lesions and biodistribution
- timeFrame
- 1 year
- description
- At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPC3 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1: Voluntarily participate and the person or their legal representative can sign an informed consent form * 2: Adult patients (18 years of age or older), regardless of gender * 3: Patients with newly diagnosed hepatocellular carcinoma with high clinical suspicion or confirmation (supporting evidence including imaging data and histopathologic examination, etc.) who agree to undergo histopathologic examination (if not performed prior to imaging) or/and 18F-FDG PET imaging * 4: Healthy volunteer * 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment * 6: Willing and able to follow schedule visits, treatment plans and laboratory tests Exclusion Criteria: * 1: Pregnant or lactating patients * 2: The patient or their legal representative is unable or unwilling to sign the informed consent form * 3: Acute systemic diseases and electrolyte disorders * 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients * 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG * 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.) * 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment
References
Publications (1)
- DERIVEDLin Z, Hu W, Li M, Pan Z, Feng Y, Zhang X, Yang B, Gai Y, Jiang D, Zhu J, Cai X, Lan X. Glypican-3-targeted immunoPET imaging of hepatocellular carcinoma: a translational study. Eur J Nucl Med Mol Imaging. 2026 May;53(6):3891-3903. doi: 10.1007/s00259-025-07739-5. Epub 2026 Feb 14. PMID 41688850