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Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma

RecruitingEARLY Phase 1Ages 18 Years - 65 YearsAllUnion Hospital, Tongji Medical College, Huazhong …
NCT06383520 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • 68Ga-aGPC3-scFv/Fab
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Where

1 site
China, Hubei Province
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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